MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ALIGNMENT DEVICE

Catalog Number UNK ALIGNMENT DEVICE

Device Problem Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

(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 the ankle clamp and em tibia jig stuck together and blue screw broke off.Screw broke off trying to get them unstuck.No surgical delay.

Manufacturer Narrative

This product was reported in error as the event description was describing a subcomponent of 950501229 hp em tibial jig ankle clamp which is captured under mfr # 1818910-2020-19592.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

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: UNK ALIGNMENT DEVICE
• Type of Device: ALIGNMENT DEVICE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10505562
• MDR Text Key: 207171406
• Report Number: 1818910-2020-19593
• Device Sequence Number: 1
• Product Code: IQO
• 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,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ALIGNMENT DEVICE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 09/08/2020; 09/18/2020
• Supplement Dates FDA Received: 09/16/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR