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	12/09/2025
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.
Event or Problem Description
It was reported that the instrument was broken upon arrival.
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 the instrument was broken when it arrived.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the internal rod of the reclaim distal stem inserter was broken.No other damage was found.The observed condition of the device appears consistent with a random component failure potentially caused by exposure to unintended forces.These forces could include repeated impactions applied while the device was not fully seated or was misaligned off-axis with its mating device.As per reclaim modular revision hip system surgical technique, "connect the distal stem inserter to the distal stem implant that corresponds to the size of the last distal reamer used.Ensure that the key feature on the proximal end of the distal stem aligns with the word ¿apex¿ etched on the distal stem inserter before rotating the knob at the end of the handle to engage the threads.Angled distal stems are oriented so that the distal stem key feature is in line with the apex of the distal stem.The location of the size etch on the distal stem is also in line with the stem¿s apex.Ensure that the distal stem apex aligns with the curvature of the anterior bow of the femur prior to distal stem impaction.To remove the distal stem inserter, rotate the knob at the end of the handle to disengage the threads".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 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.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: 23853800
• Report Number: 1818910-2025-22295
• Device Sequence Number: 10116877
• Product Code: HWR
• UDI-Device Identifier: 10603295156161
• UDI-Public: (01)10603295156161(10)SO2069262
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2025

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: 297500800
• Device Lot Number: SO2069262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/04/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/08/2026; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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