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

Catalog Number UNK FIXATION PIN

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that a threaded headed pin became lodged in the tibial resection guide while trying to remove the pin after resection.There was no surgical delay reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not received.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: UNK FIXATION PIN
• Type of Device: FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10763515
• MDR Text Key: 215568019
• Report Number: 1818910-2020-23676
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FIXATION PIN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR