MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CUTTING INSTRUMENT

Catalog Number UNK CUTTING INSTRUMENT

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

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 the patient underwent a left total knee.During the procedure, at some point the blade broke.After it broke, one piece was identified, the second was not.Carm was brought into the room to confirm no pieces were retained.Rep has advised facility to stop using these blades due to multiple breakages.There was surgical delay of 25 minutes for xray.

• Brand Name: UNK CUTTING INSTRUMENT
• Type of Device: CUTTING INSTRUMENT
• 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 ; 6107428552
• MDR Report Key: 11056499
• MDR Text Key: 225590802
• Report Number: 1818910-2020-27486
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CUTTING INSTRUMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1