MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR CON NEU+4 32ID54OD; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number 221832654

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that the instruments were reported for an unknown reason.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the snap ring of the pin trl lnr con neu+4 32id54od is missing, the device exhibits signs of nick around the the hole where the snap ring and the screw are positioned.The observed condition of the device can be attributed to an excessive force applied on liner trial when tightening.Over-tightening the threaded insert during use can cause disassembling the snap ring from the screw.Also the device exhibited slightly scratches on the outer and inner surface of the device.This type of damage is consistent with the device being in a unintended contact with other tools during assembling/disassembling the device.Properly handling and attention to the approved use of the device diminished the risk of failure.Therefore, the report allegation can be confirmed.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the pin trl lnr con neu+4 32id54od 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 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 records evaluation (mre) was not performed.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.

Event Description

The instruments were reported for an unknown reason.Visual inspection of the returned sample revealed that the snap ring of the pin trl lnr con neu+4 32id54od is missing, the device exhibits signs of nick around the the hole where the snap ring and the screw are positioned.

• Brand Name: PIN TRL LNR CON NEU+4 32ID54OD
• 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: 18985536
• MDR Text Key: 338683379
• Report Number: 1818910-2024-06776
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295101123
• UDI-Public: 10603295101123
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221832654
• Device Lot Number: PG285126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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