NA 323.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10886982190581), received between May 17, 2017 and Mar 28, 2025 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 28, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR SUPRACONDYLAR FRACTURE OF THE FEMUR WITH TYPE C. THE DEVICES WERE USED TO ASSIST IN FIXATION OF MEDIAL CONDYLE. THEY WERE INSTALLED AT ANTERIOR, AND THE SURGEON TRIED TO BEND THE EDGE OF THE DEVICES WITH A PLIER BY ATTACHING THE SLEEVE. HOWEVER, THE SLEEVE TIP BROKE OFF AND CAME OFF THE PLATE. IT WAS DIFFICULT TO REMOVE THE BROKEN FRAGMENT FROM THE PLATE, SO THE OTHER SLEEVE AND ONE SIZE LONGER PLATE WERE USED FOR THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719536 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH THE DRILL GUIDE AND THE PLATE FOR THE ULNAR DIAPHYSEAL FRACTURE. THE SURGEON ATTEMPTED TO ATTACH THE DRILL GUIDE TO THE SCREW HOLE OF THE PLATE, AND IT DID NOT WORK SMOOTHLY. WHEN THE SURGEON APPLIED MORE FORCE, THE DRILL GUIDE COULD NOT BE REMOVED FROM THE PLATE. THE SURGERY WAS COMPLETE SUCCESSFULLY WITHIN 30 MINUTES DELAY. THIS REPORT INVOLVES ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20041030 ↗
• MalfunctionFeb 1, 2024Inaccurate Information; Inaccurate Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE PROCEDURE THE DRILL BIT REF WAS REMOVED BUT THERE WAS NO EDGE. THERE WAS A DELAY THE PROCEDURE. THE DRILL BIT REF WAS BROKEN BUT DID NOT AFFECT THE PROCEDURE. THE LCP GUIDES DO NOT MATCH THE BATCH OF THE REFERRAL. IT WAS ALSO REPORTED THAT THE HEAD WAS IN POOR CONDITION AND NOT USED IN SURGERY. IT DOES NOT AFFECT THE PATIENT. THIS REPORT IS FOR ONE 2.8MM THREADED DRILL GUIDE FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627301 ↗
• MalfunctionOct 24, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TIP OF THE DRILL SLEEVE IN QUESTION WAS BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17995800 ↗
• MalfunctionMar 8, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THERE WAS A MISSING UNIT, LCP DRILL SLEEVE 3.5 F/DRILL BITS Ø2.8. ALSO, THE METER IS CROOKED. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504579 ↗
• MalfunctionDec 23, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE 2.8 MM DRILL BIT TWISTED AND TRAPPED IN THE LCP DRILL GUIDE. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 3.5 F/DRILL BITS Ø2.8 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16042712 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE SURGEON HAD DIFFICULTIES USING THE DRILL SLEEVES WITH THE PLATE. UNKNOWN IF SURGERY WAS DELAYED. THE PROCEDURES WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME IS FINE. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 3.5 F/DRILL BIT Ø2.8. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324251 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE SURGEON HAD DIFFICULTIES USING THE DRILL SLEEVES WITH THE PLATE. UNKNOWN IF SURGERY WAS DELAYED. THE PROCEDURES WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME IS FINE. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 3.5 F/DRILL BIT Ø2.8 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324213 ↗
• MalfunctionAug 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR FRACTURE OF SHAFT OF ULNA. WHEN THE SURGEON ATTACHED THE DRILL GUIDE TO A PLATE AND TRIED TO INSERT A K-WIRE SLEEVE TO THE DRILL GUIDE, THE SURGEON HAD A DIFFICULTY IN INSERTING THE K-WIRE SLEEVE TO THE DRILL GUIDE. THERE SEEMED TO BE NO PROBLEM WITH THE K-WIRE SLEEVE SINCE THE SURGEON COULD INSERT THE K-WIRE SLEEVE TO ANOTHER DRILL GUIDE NORMALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235253 ↗
• MalfunctionJul 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN ORIF SURGERY FOR PROXIMAL TIBIAL FRACTURE. WHEN HE ATTACHED THE DRILL SLEEVE TO THE 7-HOLE PLATE AND DETACHED THE DRILL SLEEVE AFTER THAT, TIP OF THE DRILL SLEEVE BROKE, AND IT GOT STUCK TO THE THREADED PART OF THE PLATE. HE TRIED TO REMOVE THE BROKEN TIP OF THE DRILL SLEEVE USING FORCEPS AND A DRILL BIT, BUT HE COULDN¿T. HE GAVE UP USING THE PLATE AND USED ANOTHER 8-HOLE PLATE EVENTUALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LCP DRILL SLEEVE 3.5 F/DRILL BIT Ø2.8 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066372 ↗
• MalfunctionFeb 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE DRILL SLEEVE DID NOT LOCK INTO THE PLATE PROPERLY. ANOTHER DRILL SLEEVE WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619995 ↗
• MalfunctionDec 14, 2021Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR TIBIAL PLATEAU FRACTURE. AS THE DRILL SLEEVE SEEMED TO BE LOOSE DUE TO THE POOR ENGAGEMENT WITH A PLATE. ANOTHER DRILL SLEEVE WAS USED, AND THE DRILL SLEEVE COULD BE ENGAGED WITH THE PLATE WITHOUT LOOSENING. THE SURGERY WAS COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004767 ↗
• MalfunctionSep 28, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A 2.8MM THREADED DRILL GUIDE IS BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543914 ↗
• MalfunctionOct 4, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY BY USING THE LCP DRILL SLEEVE IN QUESTION. DURING THE SURGERY THE SCREW PART OF THE LCP DRILL SLEEVE BROKE WHILE ATTACHING TO THE PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10624781 ↗
• MalfunctionAug 12, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE DRILL GUIDE WAS DISCOVERED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396653 ↗
• MalfunctionNov 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR CLAVICLE SHAFT FRACTURE WITH THE LCP SUPERIOR ANTERIOR CLAVICLE PLATE AND THE LCP DRILL SLEEVE IN QUESTION. DURING THE SURGERY, THE SURGEON BENT THE PLATE. WHEN THE SURGEON ATTACHED THE DRILL SLEEVE TO THE PLATE, THE BIT OF THE DRILL SLEEVE BROKE. THE SURGEON COULD NOT REMOVE THE FRAGMENT OF THE DRILL SLEEVE FROM THE PLATE COMPLETELY. THE SURGEON USED ANOTHER CLAVICLE PLATE INSTEAD AND COMPLETED THE SURGERY SUCCESSFULLY. THE SURGERY WAS DELAYED BY LESS THAN 30MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 1 OF 2 FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9268131 ↗
• MalfunctionJun 21, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN ANKLE FRACTURE ON (B)(6) 2019, THE DRILL SLEEVE WAS BROKEN, AND THE REMAINING PART WAS STUCK IN AN UNKNOWN PLATE, CAUSING THE PLATE TO BE OBSOLETE. A NEW PLATE WAS USED FOR THE SURGERY. THERE WAS ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE NO MEDICAL INTERVENTION WAS NEEDED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTE DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 2.8 MM THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722545 ↗
• InjuryFeb 5, 2019Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY DUE TO A PROXIMAL TIBIA FRACTURE ON (B)(6) 2019, THE TIP OF THE LOCKING COMPRESSION PLATE (LCP) DRILL SLEEVE WAS BROKEN AND REMAINED INSIDE THE PATIENT'S BODY. THE ISSUE HAPPENED WHEN AN UNKNOWN LOCKING COMPRESSION METAPHYSEAL PLATE WAS USED TO FIX THE POSTERIOR SIDE OF THE PROXIMAL TIBIA. AT THAT TIME, THE THIN PORTION OF THE PLATE WAS SLIGHTLY BENT. THEN, THE SURGEON TRIED TO ATTACH THE LCP DRILL SLEEVE TO A HOLE ON THE BENT PORTION OF THE PLATE, BUT IT WAS UNSUCCESSFUL. THUS, THE SURGEON HAD TO STOP DOING IT, INSERTED AND FIXED THE UNKNOWN SCREWS ON THE OTHER HOLES. THEN, WHEN THE SURGEON TRIED TO ATTACH THE DRILL SLEEVE TO THE AFFECTED HOLE, IT WAS SUCCESSFUL THIS TIME. AN X-RAY WAS TAKEN SHORTLY AFTER THE SURGERY, BUT THE SURGEON FAILED TO RECOGNIZE THAT THERE WAS A BROKEN PIECE LEFT IN THE PATIENT'S BODY. EVENTUALLY, WHEN THE SURGEON CHECKED AGAIN THE X-RAY, THE SURGEON FOUND OUT THAT A BROKEN PIECE OF THE DRILL SLEEVE WAS REMAINED IN THE PATIENT'S BODY. ON (B)(6) 2019, THE PATIENT UNDERWENT A RE-OPERATION TO REMOVE THE BROKEN PIECE/

  Patient problems: Foreign Body In Patient

  MAUDE report 8304828 ↗
• MalfunctionSep 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED IN THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO THE FIBULA ON (B)(6) 2017. IT WAS FOUND THAT THE DRILL GUIDES IN QUESTION COULD NOT BE LOCKED TO THE PLATE. SO, THE SURGEON DRILLED THE BONE MANUALLY. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6858776 ↗
• MalfunctionSep 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED IN THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO THE FIBULA ON (B)(6) 2017. IT WAS FOUND THAT THE DRILL GUIDES IN QUESTION COULD NOT BE LOCKED TO THE PLATE. SO, THE SURGEON DRILLED THE BONE MANUALLY. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6858759 ↗
• MalfunctionSep 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED IN THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO THE FIBULA (B)(6) 2017. IT WAS FOUND THAT THE DRILL GUIDES IN QUESTION COULD NOT BE LOCKED TO THE PLATE. SO, THE SURGEON DRILLED THE BONE MANUALLY. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6858750 ↗
• MalfunctionSep 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE USED IN THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TO THE FIBULA ON (B)(6) 2017. IT WAS FOUND THAT THE DRILL GUIDES IN QUESTION COULD NOT BE LOCKED TO THE PLATE. SO, THE SURGEON DRILLED THE BONE MANUALLY. NO DELAY IN SURGERY OR ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.8MM THREADED DRILL GUIDE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6858738 ↗
• MalfunctionJun 13, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) U AS FOLLOWS: IT WAS REPORTED THAT THE THREADED TIP OF TWO DRILL SLEEVES BROKE OFF. THE ISSUE WAS DETECTED ON (B)(6) 2017. IT'S UNKNOWN WHEN THE BREAKAGES OCCURRED. BUT THERE WAS NO PATIENT INVOLVEMENT. COMPLAINT INVOLVES 1 PART. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6639050 ↗
• MalfunctionJun 13, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE THREADED TIP OF TWO DRILL SLEEVES BROKE OFF. THE ISSUE WAS DETECTED ON (B)(6) 2017. IT'S UNKNOWN WHEN THE BREAKAGES OCCURRED. BUT THERE WAS NO PATIENT INVOLVEMENT. COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6639041 ↗
• MalfunctionMay 17, 2017Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A LOANER SET WAS RECEIVED AT THE AFFILIATE WITH A BROKEN THREADED DRILL GUIDE. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) THREADED DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6572407 ↗