MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE TRIAL SPA 14B; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	538002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument was broken.
Additional Manufacturer Narrative
(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.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).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.H10 additional narrative: added: d4, d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: it was reported, that the instrument was broken.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found, the s-rom*sleeve trial spa 14b, broken at the proximal coupling area.Additionally, stripped patterns were observed, on the edge of the threads.The observed, condition of the device can be attributed to unintended user error by improper alignment and care when assembling and/or impacting the mating device.Properly handling and attention to the approved use of the device diminishes the risk of failure.Depuy synthes s-rom® modular hip system, surgical technique states, the following on page 16: "gently impact the trial sleeve into the prepared metaphysis.Seat the trial sleeve completely and withdraw the introducer handle.At this point, evaluate the sleeve in relation to its final position".Where stripped patterns were found, damage can be consistent with other tools and hard edges coming in contact with the device.A dimensional inspection was not performed, since it was not applicable to the complaint condition.A functional test was unable to be performed, due to the post-manufacturing damage.The overall complaint was confirmed.As the observed, condition of the s-rom*sleeve trial spa 14b, would contribute 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 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.

• Common Device Name: HIP INSTRUMENTS : 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: 18967340
• Report Number: 1818910-2024-06427
• Device Sequence Number: 6279623
• Product Code: HWT
• UDI-Device Identifier: 10603295173298
• UDI-Public: 10603295173298
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 03/25/2024

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: 538002
• Device Lot Number: MT36597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 05/09/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/25/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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