NA 02.211.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982053701), received between Jul 9, 2018 and May 3, 2021 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.7MM VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK INTO THE FOURTH MOST PROXIMAL HOLE OF THE 2.7MM/3.5MM VARIABLE ANGLE LCP POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT. BOTH IMPLANTS REMAINED IN THE PATIENT. THE 4.0MM CANNULATED SCREW SHORT AND 4.0MM CANNULATED SCREW SHORT THREAD 64MM WERE STRIPPED OR THE CANNULATED HEX SCREWDRIVER WAS STRIPPED. A SECOND SET FOR ANOTHER SCREWDRIVER WAS OPENED AND THE HANDLE BROKE. BOTH SCREWS REMAINED IN THE PATIENT. THERE WAS TEN (10) MINUTES OF SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 38MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760138 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION. THE SURGERY PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. IMPLANT DATE: (B)(6) 2020. EXPLANT DATE: (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11230728 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION: THE SURGERY PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. IMPLANT DATE (MM/DD/YYYY): (B)(6) 2020; EXPLANT DATE (MM/DD/YYYY): (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11230725 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT INFORMATION: THE SURGERY PROCEDURE WAS PERFORMED TO REMOVE THE IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. IMPLANT DATE (MM/DD/YYYY): (B)(6) 2020 EXPLANT DATE (MM/DD/YYYY): (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11230658 ↗
• MalfunctionDec 11, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE 2.7MM VARIABLE ANGLE (VA) LOCKING SCREW SELF-TAPING WITH T8 STARDRIVE RECESS WOULD NOT LOCK INTO 2.7MM VARIABLE ANGLE LOCKING CALCANEAL PLATE LARGE 70MM LEFT AND HOLE IN PLATE WOULD NOT ACCEPT LOCKING SCREW. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 2.7MM VA LOCKNG SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 38MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10993534 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. ONE (1) 2.7 MM VARIABLE ANGLE LOCKING SCREW 40MM WAS FOUND BROKEN DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT THE 2.7 MM VARIABLE ANGLE LOCKING SCREW 4MM. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 38MM. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT INVOLVES TOTAL 23 DEVICES. (B)(4) REPORTS 10 DEVICES, ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10620455 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 7 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

  Patient problems: Pain

  MAUDE report 10619200 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10619034 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10618985 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10618965 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10618939 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10618918 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO PAIN. IT WAS NOTED ONE (1) BROKEN SCREW WAS FOUND DURING THE REVISION SURGERY. THIS WAS NOT KNOWN PRIOR TO THE SURGERY. ALL HARDWARE WAS COMPLETELY REMOVED EXCEPT A 2.7 MM VARIABLE ANGLE LOCKING SCREW. THE HEAD OF THE SCREW WAS REMOVED BUT THE SHAFT OF IT REMAINED IN THE PATIENT. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10618890 ↗
• InjuryMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 3 OF 10 FOR (B)(4) . THIS COMPLAINT HAS BEEN UPDATED WITH THE 3 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture

  MAUDE report 8640289 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OSTEOTOMY OF THE OLECRANON ON (B)(6) 2018 TO FIX THE HUMERUS. THE OSTEOTOMY WAS REPAIRED WITH AN OLECRANON PLATE, 2 CORTEX SCREWS, AND 4 VARIABLE ANGLE (VA) LOCKING SCREWS. ON (B)(6) 2018 THE PATIENT HAD A REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE DUE TO NON-UNION. IT WAS NOTED THAT THE PROXIMAL OLECRANON DID NOT HEAL AND THE PIECE OF BONE CAME OUT OF THE SCREW PLATE CONSTRUCT, AND PATIENT ALSO EXPERIENCED MALUNION AND DECREASED RANGE OF MOTION. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS' PROXIMAL OLECRANON WAS REMOVED AND THE PATIENT OUTCOME WAS STABLE. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7671480 ↗