MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT 40IDX56OD; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number 221840056

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

The instrument was reported for an unknown reason.It did not happen in surgery.It was unknown if there was any surgical delay.Additional information per investigational findings: visual analysis of the returned device found that the pin trl lnr neut 40idx56od has signs of scratches at the surface.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.Additionally the snap ring and the screw were missing, it is to possible that these two components were most likely disassembled due to over tightening.However the potential cause for the missing screw and ring cannot be determined.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the instrument was reported for an unknown reason.It did not happen in surgery.It was unknown if there was any surgical delay.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 40idx56od has signs of scratches at the surface.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 trailing.Properly handling and attention to the approved use of the device diminishes the risk of failure.Additionally the snap ring and the screw were missing, it is to possible that these two components were most likely disassembled due to over tightening.However the potential cause for the missing screw and ring cannot be determined.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 : the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.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.

• Brand Name: PIN TRL LNR NEUT 40IDX56OD
• Type of Device: HIP INSTRUMENTS : ACETABULAR 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 ; 3035526892
• MDR Report Key: 18520487
• MDR Text Key: 333257694
• Report Number: 1818910-2024-01067
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295430018
• UDI-Public: 10603295430018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221840056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1