NA 201.356.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982141811), received between May 24, 2019 and Oct 2, 2020 — classified as 11 injuries.

4 other recalls cover devices cleared under the same FDA submission (K063049); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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) 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 6MM. THIS IS REPORT 8 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 10620553 ↗
• 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 10 OF 10 FOR (B)(4). THIS IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10619286 ↗
• 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 9 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10619276 ↗
• 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 8 OF 10 FOR (B)(4) THIS COMPLAINT IS LINKED TO (B)(4) AND (B)(4).

  Patient problems: Pain

  MAUDE report 10619256 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM (PART NUMBER 201.362.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 16MM (PART NUMBER 201.366.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART NUMBER 201.368.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM (PART NUMBER 201.370.97, LOT UNKNOWN, QUANTITY 1), 2.0MM LCP(TM) PLATE 4 HOLES/31MM (PART NUMBER 247.344, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 20MM (PART NUMBER 204.82, LOT UNKNOWN, QUAN

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10442402 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 4 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 24 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: No Code Available

  MAUDE report 8641443 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 6 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 26 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4), (B)(4), AND (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: No Code Available

  MAUDE report 8641435 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 5 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 25 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: No Code Available

  MAUDE report 8641433 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 2 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 22 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: No Code Available

  MAUDE report 8641429 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 3 OF 9 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 23 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4) FOR ADDITIONAL DEVICES.

  Patient problems: No Code Available

  MAUDE report 8641419 ↗
• 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 10 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 10 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 8640685 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen