MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HANDLE SLEEVE DRIVER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	535801
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a tha surgery for osteoarthritis of the left hip.During the surgery, the introducer sleeve body and handle were detached easily.Eventually, the handle slipped out and became unclean, so the introducer sleeve body had to be removed by striking it from the opposite direction with a bone fragment hammer.The surgery was completed successfully within 30 minutes delay.There was no patient harm.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: udi: as a valid lot number for the device involved in the event was not provided, the full udi is currently not available.H4: manufacture date is an unknown day in july 2007.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that on (b)(6) 2025, the patient underwent a tha surgery for osteoarthritis of the left hip.During the surgery, the introducer sleeve body and handle were detached easily.Eventually, the handle slipped out and became unclean, so the introducer sleeve body had to be removed by striking it from the opposite direction with a bone fragment hammer.The surgery was completed successfully within 30 minutes delay.Investigation for reasons why they are so easily detached and solutions are requested.No further information is available.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the s-rom*handle sleeve driver had signs of wear consistent with repeated use over the years.A functional test was performed, and the s-rom*handle sleeve driver was successfully assembled without any issues.There were no signs of looseness or difficulties in attaching or holding its mating device.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the s-rom*handle sleeve driver would not have contributed to the complained issue.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 reported complaint condition.As part of j&j 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (ht0807) provided is not a valid finished goods lot number.

• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21679942
• Report Number: 1818910-2025-04452
• Device Sequence Number: 12662461
• Product Code: HWR
• UDI-Device Identifier: 10603295172710
• UDI-Public: (01)10603295172710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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: 535801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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