MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SOCKET WRENCH-11MM WIDTH ACROSS FLATS

Model Number	321.15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, the instrument broke during clamp removal.There was no consequence to the patient.This report involves one (1) socket wrench-11mm width across flats.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: part: 321.150, lot: 8348966, manufacturing site: bettlach, release to warehouse date: april 10, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the socket wrench- 11 mm width across flats was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was missing the cylindrical pin (p/n: 000.513) and headpiece (p/n: 000.762) components.There were scratches on the shaft but have no impact on the device functionality.No other issues were observed with the returned device.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Socket wrench hex11, headpiece, stift.Investigation conclusion: the complaint condition was confirmed for the socket wrench- 11 mm width across flats.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: SOCKET WRENCH-11MM WIDTH ACROSS FLATS
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11581563
• Report Number: 2939274-2021-01555
• Device Sequence Number: 4182708
• Product Code: HXC
• UDI-Device Identifier: 10886982190383
• UDI-Public: (01)10886982190383
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 321.15
• Device Catalogue Number: 321.15
• Device Lot Number: 8348966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/05/2021
• 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 - CRANIAL CLAMPS/CLIPS.