MAUDE Adverse Event Report: SYNTHES GMBH REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET

Catalog Number	399.124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery for the femoral diaphysis fracture.When the surgeon used the reduction forceps to reduce the femoral diaphysis, the right end of the reduction forceps was broken about 1 cm.The surgery was completed successfully without any surgical delay.The patient outcome was stable.This complaint involves one (1) device.This report is for (1) reduction forceps w/serrated jaw-large handle-soft ratchet.This report is 1 of 1 (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.H3, h4, h6: part 399.124, lot 5943724: manufacturing site: salzburg.Release to warehouse date: september 25, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that one of the jaws of the forceps was broken and the broken piece was not returned.No other issues were identified.The dimensional inspection was not performed due to post manufacturing damage.The observed broken condition of the components is consistent with the complaint condition.The device was consistent with a random component failure that may have been caused by exposure to unintended forces.The drawing reflecting the current and manufacture revision was reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed.While no definitive root cause could be determined, it is probable component was broken due to the unintended/overt forces.There was no indication that a design or manufacturing issue contributed to the complaint.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.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: REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11631321
• Report Number: 8030965-2021-02691
• Device Sequence Number: 3843607
• Product Code: HTD
• UDI-Device Identifier: 07611819221048
• UDI-Public: (01)07611819221048
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 399.124
• Device Lot Number: 5943724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1