MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 16MM; KNEE INSTRUMENT : REAMERS

Model Number 2178-63-176

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 06/18/2020

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 end of size 16 reamer is rounded off, due to wear would not stay connected to the adapter.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: update 10-aug-2020: the investigation was re-opened upon the receipt of the product.Examination of the returned device confirmed the reported event.The investigation attributed the root cause to normal use and servicing and did not establish that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

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.

• Brand Name: MBT REVISION REAMER 16MM
• Type of Device: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10217693
• MDR Text Key: 197113253
• Report Number: 1818910-2020-14794
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295096337
• UDI-Public: 10603295096337
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2178-63-176
• Device Catalogue Number: 217863176
• Device Lot Number: A1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR