MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM PROX NECK TRL 45MM; FEMORAL TRIALS

Catalog Number	297531045
Medical Device Problem Codes	Device-Device Incompatibility (2919); Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reclaim 45mm neck trial has a loose metal ring around the top of the neck, preventing a head-ball trial from fitting properly.Surgery time was not extended.No pieces were dislodged from the instrument.
Additional Manufacturer Narrative
Product complaint (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary no device associated with this report was received for examination.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 records evaluation (mre) was not performed.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.If additional information is made available, the investigation will be updated as applicable.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.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
Additional information received states that there was no adverse consequences that affected the patient.
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 that 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.Added: a1, b5, 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 reclaim 45mm neck trial has a loose metal ring around the top of the neck, preventing a headball trial from fitting properly.Surgery time was not extended, no pieces were dislodged from the instrument.The product was returned to depuy synthes for evaluation.Visual examination found nothing indicative of a device nonconformance.Functional test was performed and the device was able to assemble, hold its mating component and disassemble as intended.No functionally issues were identified.The overall complaint was unconfirmed as the observed condition of the reclaim prox neck trl 45mm would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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.

• Brand Name: RECLAIM PROX NECK TRL 45MM
• Common Device Name: FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19475177
• Report Number: 1818910-2024-12387
• Device Sequence Number: 6913850
• Product Code: HWT
• UDI-Device Identifier: 10603295156376
• UDI-Public: (01)10603295156376(10)SO2034040
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 06/06/2024

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: 297531045
• Device Lot Number: SO2034040
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/20/2024; 07/11/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/23/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2018
• 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