MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 12MM; KNEE INSTRUMENT : REAMERS

Model Number 2178-63-172

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

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 size 10 and 12 revision reamer would stick while attached in t-handle and was difficult remove.All other sizes used would not stick.There was a 30 second delay in the case.Lot numbers on both reamers unavailable not able to read.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT REVISION REAMER 12MM
• Type of Device: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11693998
• MDR Text Key: 246281280
• Report Number: 1818910-2021-08304
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295096290
• UDI-Public: 10603295096290
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2178-63-172
• Device Catalogue Number: 217863172
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1