MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 MBT REVISION REAMER 16MM; KNEE INSTRUMENT : REAMERS

Catalog Number 217863176

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

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 mbt reamers slipping in the modified hudson adapter while reaming bone.No surgical delay.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: functional testing of the returned device confirmed the reported event.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REVISION REAMER 16MM
• Type of Device: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7227263
• MDR Text Key: 98633703
• Report Number: 1818910-2018-52337
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295096337
• UDI-Public: 10603295096337
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 217863176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR