MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PIN TRL LNR NEUT 56ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221832056
Medical Device Problem Codes	Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Routine inspection of instruments.Opened 4 different sets of trays to inspect items.Multiple items with scratches and wear and tear requiring replacement.There was no patient consequence reported.
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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: routine inspection of instruments.Opened 4 different sets of trays to inspect items.Multiple items with scratches and wear and tear requiring replacement.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the pin trl lnr neut has signs of deep scratches at the surface and at the screw head.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces, like usage of forceps, tweezers, sharp tools, etc.While trialing.Properly handling and attention to the approved use of the device diminishes the risk of failure.Additionally the device presents signs of heavily stripped at the screw head, most likely cause due to over torquing.The overall complaint was confirmed as the observed condition of the pin trl lnr neut would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error and 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 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): a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (sz0908) provided is not a valid finished goods lot#.

• Brand Name: PIN TRL LNR NEUT 56ODX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 17920193
• Report Number: 1818910-2023-20780
• Device Sequence Number: 6804366
• Product Code: HWT
• UDI-Device Identifier: 10603295100744
• UDI-Public: 10603295100744
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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: 221832056
• Device Lot Number: SZ0908
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 12/28/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 10/30/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2008
• 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