MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ROD FOR REAMING GUIDE HOLDER; ORTHOPEDIC INSTRUMENT HANDLE

Catalog Number	230774002
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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 on september 18, 2024 that the trial inserter was bent and would not adequately lock onto to trial.The screwdriver was beginning to round off in screw head.
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: d9 and h4 corrected: d4 (lot #, primary udi number).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 trial inserter was bent and would not adequately lock onto to trial.The screwdriver was beginning to round off in screw head.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device did not found signs of bending or deforming, just normal signs of worn.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed with the reaming guides and the rod for reaming guide holder didn't show difficulties for assembling and staying well fitted.The reported unable to assembled condition was not able to be replicated.The overall complaint was not confirmed as the observed condition of the rod for reaming guide holder would have not contributed to the complained device 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.

• Brand Name: ROD FOR REAMING GUIDE HOLDER
• Common Device Name: ORTHOPEDIC INSTRUMENT HANDLE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20303056
• Report Number: 1818910-2024-20114
• Device Sequence Number: 8883552
• Product Code: PHX
• UDI-Device Identifier: 10603295116134
• UDI-Public: (01)10603295116134(10)5373766
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 230774002
• Device Lot Number: 5373766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 11/11/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/18/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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 Age: 69 YR
• Patient Sex: Female