MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDE/FIXED HAMMER 400 GRAMS; HAMMER, SURGICAL

Model Number	03.010.058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id: (b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
It was reported that on (b)(6) 2021, the patient underwent a humeral nail case.During the procedure, the slide/fixed hammer broke into multiple pieces.No pieces remained in the patient.The procedure was successfully completed with no surgical delay.This report is for a hammer.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.H3, h4, h6- the hammer, 400 gram (p/n: 03.010.058, lot #: 4820680) was returned and received at us cq.Upon visual inspection it was found that device was received with broken pieces in the handle.Several fragments have been generated.Some of the broken fragments were not returned.The remainder of the instrument shows significant dents, wear marks and impact marks.The complaint condition is confirmed for the hammer 400 grams (p/n 03.010.058, lot 4820680).While no definitive root cause could be determined, it is possible that over 17 years of impact forces has contributed to the complaint condition.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot =part #: 03.010.058, synthes lot #: 4820680, supplier lot #: n/a , release to warehouse date: 08 dec 2004, manufactured by: brandywine, no ncr's generated during production.Device history review =review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: SLIDE/FIXED HAMMER 400 GRAMS
• Common Device Name: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12210990
• Report Number: 2939274-2021-04213
• Device Sequence Number: 3130339
• Product Code: FZY
• UDI-Device Identifier: 10886982067296
• UDI-Public: (01)10886982067296
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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 Model Number: 03.010.058
• Device Catalogue Number: 03.010.058
• Device Lot Number: 4820680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: HUMERAL; UNK - NAILS: HUMERAL