MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S/C TRIAL HANDLE; HIP INSTRUMENTS : HANDLES

Catalog Number	205512000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was received for analysis.There was no product malfunction or patient harm reported with the returned device.
Additional Manufacturer Narrative
Product complaint # (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.H3, h6 investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed signs of heavy usage on the overall device surface.Additionally, some debris was found attached to the ball plungers of the s/c trial handle.Debris attached can be traced to maintenance due to improper cleaning/sterilization process followed.Per ifu, care should be taken to remove any debris, tissue, or bone fragments that may collect on the instrument.Instruments with cannulas, moving parts, or spring mechanisms require additional cleaning steps to ensure proper removal of all trapped debris.In addition to other important steps to follow, the ifu instructs the use of a soft bristle brush to remove all traces of blood and debris, paying close attention to threads, crevices, seams, and any hard-to-reach areas of the device features.If the instrument has sliding mechanisms or hinged joints, actuate the area to free any trapped blood and debris.Based on the observed unclean condition of the device features, it does not appear the device was properly cleaned as prescribed by the ifu.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed manually for the ball plungers and using the s/c & mod cath trl 48/28 as a medtech orthopaedics sample/mating component.Functional test performed revealed a resistance in the retrieval mechanism of the ball plungers and well as the failure in the assemblance with its mating component.Potential cause can be traced to a component failure, as this condition may had happen as a consequence of the debris patterns attached to it.The overall complaint was confirmed as the observed condition of the s/c trial handle would have contributed to a 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.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: S/C TRIAL HANDLE
• Common Device Name: HIP INSTRUMENTS : HANDLES
• 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: 21699294
• Report Number: 1818910-2025-04592
• Device Sequence Number: 7695939
• Product Code: LXH
• UDI-Device Identifier: 10603295084471
• UDI-Public: (01)10603295084471(10)PG270067
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 205512000
• Device Lot Number: PG270067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2017
• 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