MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RETAINING STEM INSERTER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 259807570

Device Problem Naturally Worn (2988)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

It was reported that the inserter/extractor is cross-threaded and needs to be replaced.No time was added to surgery.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: it was reported that the inserter/extractor is cross-threaded and needs to be replaced.No time was added to surgery.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the proximal threaded area of the shaft was heavily damaged.This damage can be attributed to a combination of heavy usage and impacting the threaded rod weldment before is fully threaded in to the retaining stem inserter body.The overall complaint was confirmed as the observed condition of the retaining stem inserter would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.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 manufacturing records evaluation (mre) was not performed.

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.

Event Description

Additional information received indicates that there was no harm to the patient.

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.

• Brand Name: RETAINING STEM INSERTER
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18148343
• MDR Text Key: 328278710
• Report Number: 1818910-2023-23423
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295148548
• UDI-Public: 10603295148548
• 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,Followup,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 259807570
• Device Lot Number: AB5383794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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