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

Model Number	321.20
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
Product complaint # (b)(4).Complainant device is expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.The investigation could not be completed.No conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 an unknown date, the ratchet wrench and the universal bending pliers were broken.It is unknown when and where the issue was discovered.It is unknown if there is patient or procedure involvement.This complaint involves one (1) devices.This report is 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: part number: 321.20, synthes lot number: 5236552, supplier lot number: lm015176, release to warehouse date: may 10, 2006, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the 11mm ratchet wrench (part # 321.20, lot # lm015176, quantity # (b)(4)) was received at us customer quality (cq).Upon visual inspection, it was noticed that edges of the ratchet was deformed.There were some scratches, discoloration and part number/lot number were difficult to read.No other issues were observed with the returned components of the device.Dimensional inspection: dimensional analysis was not performed due to post manufacturing damage document/specification review: the following drawing(s) was reviewed; 11 mm ratchet wrench: manufactured and current revisions.Conclusion: the exact cause of the reported condition is unknown, but it is likely that the device is worn from repeated use and servicing during the 14+ year life of the device.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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: RATCHET 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: 11877930
• Report Number: 2939274-2021-02551
• Device Sequence Number: 16396358
• Product Code: HXC
• UDI-Device Identifier: 10886982190444
• UDI-Public: (01)10886982190444
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 321.20
• Device Catalogue Number: 321.20
• Device Lot Number: 5236552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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: UNIVERSAL BENDING PLIERS; UNIVERSAL BENDING PLIERS