MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN; SCREW, FIXATION, BONE

Catalog Number	04.211.020TS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, the patient underwent an open reduction internal fixation (orif) surgery to treat the distal clavicle with a variable angle locking compression plate (valcp)and the screws; lateral middle cs2 left.After the surgery, on (b)(6) 2024, the three (3) distal screws were found to be broken.The breakage was found after rehabilitation.The plan is not to perform a revision surgery, but to monitor the progress and try to achieve bone fusion.The patient status/outcome is reported as stable.This report is for a locking screw.This is report 2 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional product code: hrs complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a depuysynthes sales representative sterile part 04.211.020ts, lot 9l78804: manufacturing site: werk selzach logistik.Release to warehouse date: september 05, 2022.Expiration date: september 01, 2027.Supplier: früh verpackungstechnik ag.Non-sterile part 04.211.020, lot 912p100: manufacturing site: werk selzach logistik.Release to warehouse date: july 11, 2022.Supplier: synthes usa hq, inc.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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.

• Brand Name: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19468905
• Report Number: 8030965-2024-07112
• Device Sequence Number: 17985967
• Product Code: HWC
• UDI-Device Identifier: 10886982119025
• UDI-Public: 10886982119025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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 Catalogue Number: 04.211.020TS
• Device Lot Number: 9L78804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2022
• 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 - PLATES: VA-LCP; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L20 TAN
• Patient Sex: Female