MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM PRONGED STEM STBLZR; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number	297500400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device ra90430072g had a missing knob and broken lever, the device 297500400 had a missing back and top piece, the device 254401006 was cracked and chipped, the device 255000100 had a piece sticking out and is coming apart, and the device 257005000 had a cross threaded tip.It didnt happen in surgery.
Additional Manufacturer Narrative
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.H10 additional narrative: h3, h4, h6 investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the reclaim pronged stem stblzr had signs of extensive and repeated use over the years.The torque wrench adaptor was found with nicks and slight deformations.Scratches can be seen on the stem insert.However, no missing components were found.The observed condition appears to be consistent with the effects of repeated use and servicing over the years.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A functional test was not performed since it was not applicable to the complaint condition.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 reclaim pronged stem stblzr 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM PRONGED STEM STBLZR
• Common Device Name: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 22532439
• Report Number: 1818910-2025-12387
• Device Sequence Number: 7473433
• Product Code: HWR
• UDI-Device Identifier: 10603295155904
• UDI-Public: (01)10603295155904(10)NB144637
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2025

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: 297500400
• Device Lot Number: NB144637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2016
• 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