MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 CANNULATED IMPACTOR HANDLE; SHOULDER INSTRUMENT - IMPACTOR HANDLE

Catalog Number 620101141

Device Problem Naturally Worn (2988)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that the threads became stripped.This did not affect the surgery in any way.

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.

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 which 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that the threads became stripped.This did not affect the surgery in any way.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis revealed the threaded tip of the cannulated impactor handle stripped.No additional damage was observed on device surface.The damage observed at the tip can be consistent with impacting the device before the threaded tip is fully seated.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the cannulated impactor handle would have contributed to the complained 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 required.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 manufacturing records evaluation (mre) was not performed.Corrected: h3.

• Brand Name: CANNULATED IMPACTOR HANDLE
• Type of Device: SHOULDER INSTRUMENT - IMPACTOR HANDLE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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: 18987543
• MDR Text Key: 338722894
• Report Number: 1818910-2024-06834
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295539339
• UDI-Public: 10603295539339
• 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,Followup
• 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: 620101141
• Device Lot Number: 207944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2023
• 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
• Patient Age: 82 YR
• Patient Sex: Female