MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM ASSEM UPPER PULL ROD; HIP INSTRUMENTS: EXTRACTOR

Catalog Number	297500635
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
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.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 when users were trying to assemble the proximal body to the distal stem with the torque system, it seemed to be stuck/cross threaded and therefore users couldn¿t get the tensile bar to break.
Event or Problem Description
Additional information received states that there was no delay and no adverse consequences.
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.H11 additional narrative: added: b5 corrected: h6 (health effect - clinical code and health effect - impact code) 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 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Common Device Name: HIP INSTRUMENTS: EXTRACTOR
• 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: 21208447
• Report Number: 1818910-2025-01280
• Device Sequence Number: 18160524
• Product Code: HWB
• UDI-Device Identifier: 10603295156017
• UDI-Public: (01)10603295156017(10)SO2004405
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: 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: 297500635
• Device Lot Number: SO2004405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 01/31/2025; 02/26/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/05/2025; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2001
• 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: Male