MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM DISTAL STEM INSERTER; RECLAIM INSTRUMENTS : IMPACTORS

Catalog Number	297500800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
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.H11 additional manufacturer narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the rubber grip of the reclaim distal stem inserter device was torn apart during use.Unable to be properly sterilized.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees hat the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that reclaim distal stem inserter product number d297500800 rubber grip has torn apart during use.Unable to be properly sterilized.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the reclaim distal stem inserter exhibited what appear to be impaction marks on the proximal section of the black handle and beneath the plate.These impacts resulted in material fracture in the affected area.Fragments were not returned.Additionally, the internal rod was missing.Damage observed on the device can be attributed to a combination of heavy use and unintended impaction forces, likely from bottom-up impactions to disengage the device.Per reclaim surgical technique, "to remove the distal stem inserter, rotate the knob at the end of the handle to disengage the threads".Additionally, "the depth gauge can be used to assist with loosening the knob on the distal stem inserter should it be necessary by acting as a tommy bar".A root cause for the missing rod condition cannot be determined.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 confirmed as the observed condition of the reclaim distal stem inserter would 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 depuy synthes 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 (a0311) provided is not a valid finished goods lot number.Corrected: h3.

• Brand Name: RECLAIM DISTAL STEM INSERTER
• Common Device Name: RECLAIM INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24384392
• Report Number: 1818910-2026-03232
• Device Sequence Number: 10258109
• Product Code: HWR
• UDI-Device Identifier: 10603295156161
• UDI-Public: (01)10603295156161(10)A0311
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 297500800
• Device Lot Number: A0311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/25/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/20/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2011
• 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