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

Model Number	03.010.056
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.The device has been 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 an unknown date, the slide/fixed hammer for tibia nail set would not screw down, it stayed locked.The hammer did not fit in the graphic case and cannot be used.There was an unknown number surgical delay.Procedure outcome was unknown.There was no consequence to the patient.Concomitant devices reported: cases/trays/modules (part number unknown, lot unknown, quantity 1) this report involves one (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.H3, h6: investigation summary.Investigation flow: functional/device interaction.Visual inspection: the slide/fixed hammer 700 grams (p/n: 03.010.056, lot number: 1465604) was received at us cq.Visual inspection of the complaint device showed nicks and scratches on the hammer.Functional test: a functional assessment was performed on the complaint device.The captivation nut was able to tighten and loosen to hold the hammer head in position.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: no design issues or discrepancies were identified.The complaint is not confirmed.Investigation conclusion: this complaint is not confirmed as the reported condition cannot be replicated.However, the device is nicked and scratched from use.No definitive root cause could be determined based on the provided information.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 history lot: product code: 03.010.056, lot#: 1465604, manufacturing site: hägendorf, release to warehouse date: june 09, 2006.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11265544
• Report Number: 2939274-2021-00613
• Device Sequence Number: 11543393
• Product Code: FZY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 03.010.056
• Device Catalogue Number: 03.010.056
• Device Lot Number: 1465604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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 - CASES/TRAYS/MODULES