MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/16MM; SCREW, FIXATION, BONE

Model Number	04.118.516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D2b: additional device product codes: hrs d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent open reduction internal fixation (orif) surgery for a clavicle fracture with low profile metaphyseal compression screw and va-lcp clavicle plate.The surgeon used a low-profile screw to fix the regular hole because of the young patient.The surgeon drilled with a threaded drill guide as instructed in the procedure manual, and used a screwdriver without torque limiter to insert a screw.However, it reached to the lateral cortex and broke off from the head of the screw when it was slightly retightened.The screw could not be removed, but the surgeon decided to leave it in the body because it was scheduled for removal after fusion.This report involves one 2.7mm ti metaphyseal scr/slf- tpng w/t8 strdrv recess/16mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part# 04.118.516ts, lot # 9l36260, manufacturing site: werk selzach logistik, supplier: (b)(4), release to warehouse date: 09 may 2022, expiration date: 01 may 2027.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the head of the lwprof metaphys compres scr ã¸2.7 self-ta has broken, the broken fragment was not returned.No other problems were observed.A dimensional inspection was not performed for the lwprof metaphys compres scr ã¸2.7 self-ta due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.¿ the overall complaint was confirmed as the observed condition of the lwprof metaphys compres scr ã¸2.7 self-ta [04.118.516ts/9l36260] would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17005550
• Report Number: 8030965-2023-06685
• Device Sequence Number: 15026611
• Product Code: HWC
• UDI-Device Identifier: 10886982108807
• UDI-Public: (01)10886982108807
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.118.516
• Device Catalogue Number: 04.118.516TS
• Device Lot Number: 9L36260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA; UNK - SCREWDRIVERS; VA-LCP CLAVIC PL 2.7 SHAFT CS1 LE TAN
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 53 KG