MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FIXATION PIN

Catalog Number UNK FIXATION PIN

Device Problem Unstable (1667)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

Problem reported: femoral array moved during surgery, surgery was aborted and manual procedure completed.Operator error.When was the issue observed: surgery.Troubleshooting:na.Patient involvement? yes.Were there reports of injuries, medical intervention or prolonged hospitalization? no.Are patient treatments delayed or canceled? no.Next day of surgery: unknown.All information disclosed.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Email received on 09/feb/2022 from reporter, (b)(6), with additional event information.The reporter stated "the surgeon placed the pin in poor bone quality and because of that, the pin fixation weakened which resulted in the femoral array moving from its original location.The surgeon admitted he did not adequately fixate the pin and that resulted in the array moving." if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review: as there are no manufacturing/design related issues identified, there is no manufacturing review evaluation required.

• Brand Name: UNK FIXATION PIN
• Type of Device: FIXATION PIN
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13634643
• MDR Text Key: 287422246
• Report Number: 1818910-2022-03832
• Device Sequence Number: 1
• Product Code: LXH
• 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,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK FIXATION PIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1