NA 03.133.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10886982269973), received between Aug 24, 2020 and Dec 30, 2024 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (48 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR LEFT OLECRANON FRACTURE ON LEFT OLECRANON WITH THE DRILL BIT IN QUESTION. IN THE SURGERY, THE OP ROOM NURSE CONTACTED THE AGENCY REPRESENTATIVE AS FOLLOWS. THE SURGEON OPENED THE PRODUCT IN QUESTION AND TRIED TO INSERT IT INTO A 2.8MM THREADED DRILL GUIDE (03-133-004) BUT COULD NOT DO SO. THE PRODUCT COULD NOT BE INSERTED INTO ANOTHER 2.8MM THREADED DRILL GUIDE AS WELL. THE REPRESENTATIVE OF THE AGENCY ASKED THE NURSE TO OPEN ANOTHER DRILL TIP OF THE SAME PART NUMBER TO CHECK IF THE DRILL TIP COULD BE INSERTED AND HUNG UP THE PHONE. AFTER THE SURGERY, THE AGENCY VISITED THE HOSPITAL AND CHECKED THE STATUS WITH THE OP ROOM NURSE, AND HE OR SHE REPORTED THAT THE NEWLY OPENED DRILL TIP COULD BE INSERTED INTO THE 2.8 THREADED DRILL GUIDE AND THE OP WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037170 ↗
• MalfunctionDec 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY FOR LEFT OLECRANON FRACTURE ON LEFT OLECRANON WITH THE DRILL BIT IN QUESTION. IN THE SURGERY, THE OP ROOM NURSE CONTACTED THE AGENCY REPRESENTATIVE AS FOLLOWS. THE SURGEON OPENED THE PRODUCT IN QUESTION AND TRIED TO INSERT IT INTO A 2.8MM THREADED DRILL GUIDE (03-133-004), BUT COULD NOT DO SO. THE PRODUCT COULD NOT BE INSERTED INTO ANOTHER 2.8MM THREADED DRILL GUIDE AS WELL. THE REPRESENTATIVE OF THE AGENCY ASKED THE NURSE TO OPEN ANOTHER DRILL TIP OF THE SAME PART NUMBER TO CHECK IF THE DRILL TIP COULD BE INSERTED, AND HUNG UP THE PHONE. AFTER THE SURGERY, THE AGENCY VISITED THE HOSPITAL AND CHECKED THE STATUS WITH THE OP ROOM NURSE, AND HE OR SHE REPORTED THAT THE NEWLY OPENED DRILL TIP COULD BE INSERTED INTO THE 2.8 THREADED DRILL GUIDE AND THE OP WAS SUCCESSFULLY COMPLETED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037082 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT INVOLVES ONE 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 1 OF 9 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689259 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED. THIS REPORT INVOLVES ONE 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP THIS IS REPORT 2 OF 9 FOR (B)(4). ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689229 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640025 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640023 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THIRDED GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640021 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640020 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640019 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640017 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640016 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640012 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640011 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING AN UNKNOWN PROCEDURE, THE THREADED DRILL GUIDES IN QUESTION WOULD NOT THREAD INTO THE PROXIMAL HUMERUS LOCKING PLATE. THE SURGEON TRIED WITH MULTIPLE THREADED DRILL GUIDES AND ALL HAD TROUBLE THREADING INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640008 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON JANUARY 22, 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED MULITPLE THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639879 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED "MULTIPLE" THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639876 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED "MULTIPLE" THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639872 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED MULITPLE THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639866 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED MULITPLE THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639864 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED "MULTIPLE" THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639855 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED MULITPLE THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639851 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED MULITPLE THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639849 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED MULTIPLE THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639833 ↗
• MalfunctionFeb 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON JANUARY 22, 2024, THE SURGEON COMPLAINED THAT 2.8MM THREADED DRILL GUIDE FOR 3.5MM LOCKING TOWERS DO NOT THREAD INTO LOCKING PLATE (SPECIFICALLY THE PROXIMAL HUMERUS PLATE). SURGEON TRIED MULTIPLE THREADED DRILL GUIDES AND THEY ALL HAD TROUBLE THREADING INTO THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8 THRDD GUIDE F/ 3.5 SCR VA AND LCP THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18639819 ↗
• MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON JANUARY 9, 2024, IT WAS POSSIBLE TO SEPARATE THE DRILL AND DRILL GUIDE FROM EACH OTHER. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. THIS REPORT IS FOR A 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595136 ↗