MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRIAL SHELL 57 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221701057
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 that there was a stripped trial and impactor.No other information was provided at this time.
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 that 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.H11 additional narrative: added: d4 lot, d9, h4.Corrected: d4 primary udi number.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received: "stripped trial and impactor".The product was returned to medtech orthopaedics for evaluation.Visual inspection revealed the following conditions on the pin trial shell 57 std profile surface: 1) a deep scratch was found near the edge of the central threaded hole; 2) the central threaded hole was found partially stripped; and 3) the tip/insert portion of the duraloc str cup impactor was returned assembled with the pin trial shell 57 std profile.Scratches can be consistent with other tools and hard edges coming in contact with the device.Properly handling and attention to the approved use of the device diminishes the risk of failure.The observed condition of the threaded tip was consistent with off-axis assembly and impacting device before the threaded tip of the mating component was fully seated into the cup.Properly handling and attention to the approved use of the device diminishes the risk of failure.The functional test performed revealed that the tip/insert portion of duraloc str cup impactor was unable to disassemble from the pin trial shell 57 std profile.Potential cause for these allegations can be traced to failure component as this type of damage comes as a consequence of the combination between the stripped conditions on both devices.A dimensional inspection was not performed since it was not applicable to the complaint condition.A device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code wb0408 provided is not a valid finished goods lot number.The overall complaint was confirmed as the observed condition of the pin trial shell 57 std profile 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 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 a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code wb0408 provided is not a valid finished goods lot number.

• Brand Name: PIN TRIAL SHELL 57 STD PROFILE
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• 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: 21283914
• Report Number: 1818910-2025-01853
• Device Sequence Number: 7908458
• Product Code: HWT
• UDI-Device Identifier: 10603295097686
• UDI-Public: (01)10603295097686(10)WB0408
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/31/2025

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: 221701057
• Device Lot Number: WB0408
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/10/2025; 03/18/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/13/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2008
• 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