MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIV REV FEM BROACH REAMER; KNEE INSTRUMENT : BROACHES

Catalog Number	961671
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported the rubber seals on several trials were torn.There was no procedure or patient involvement.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, " cssd is complaining the rubber seals on several trials are massively torn.Seen in cssd.No patient involvement, no surgical delay." the product was not returned to medtech orthopaedics, however photos were provided for review.See attachment (pc-(b)(4) photo).The device associated with this report was not returned to medtech orthopaedics for evaluation.The photographs attached were reviewed, however the image quality is poor and no observations pertaining to the nature of the reported event could be identified.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs attached are insufficient to draw a conclusion about the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNIV REV FEM BROACH REAMER
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22036560
• Report Number: 1818910-2025-08024
• Device Sequence Number: 20920549
• Product Code: HTQ
• UDI-Device Identifier: 10603295239772
• UDI-Public: (01)10603295239772
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 961671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown