MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIDE/FIXED HAMMER 700 GRAMS; GUIDE

Model Number	03.010.056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, 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
It was reported that on (b)(6) 2021, during insertion of a tibial nail in accordance with proper technique, the combined hammer handle split.The combined hammer was passed off the field and a different hammer was used for continued insertion of the nail without procedure interruption.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) slide/fixed hammer 700 grams.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.H10 additional narrative: h3, h6: investigation summary investigation flow: broken visual inspection: slide/fixed hammer 700 grams (part# 03.010.056, lot# unknown, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the handle of the device was broken.The pin welded on the hammer shaft also got broken.Few broken fragments of the handle and the broken pin were not returned at cq.The handle got broken across the lot number on the device and the lot number is illegible.Rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Pictures attached were also reviewed and no additional defects were identified.Device failure/defect is identified.Dimensional inspection: dimensional inspection of the received device was not performed at cq due to post manufacturing damage document/specification review no design issues or discrepancies were found during this investigation.The complaint is confirmed.The handle of the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint is being confirmed for slide/fixed hammer 700 grams (part# 03.010.056, lot# unknown) as the handle of the device was broken.While a definitive root cause could not be identified for the reported problem, it is possible that the handle of the device might have encountered unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 history lot a manufacturing record evaluation could not be performed as the lot number could not be determined.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 700 GRAMS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11267853
• Report Number: 2939274-2021-00625
• Device Sequence Number: 3302627
• Product Code: FZX
• UDI-Device Identifier: 10886982067289
• UDI-Public: (01)10886982067289
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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 Expiration Date: 05/06/2025
• Device Model Number: 03.010.056
• Device Catalogue Number: 03.010.056
• Device Lot Number: 4837841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/16/2021
• Patient Sequence Number: 1
• Patient Age: 83 YR