MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 MBT REVISION REAMER 21MM; REAMERS

Catalog Number	217863181
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the surgeon was reaming the tibia and the mbt revision reamers were spinning inside the modified hudson adapter connection and t-handle connection.This required having to use several different hudson adapters to complete the reaming.As a result, the reamers and adapters are no longer functioning correctly.There were no pieces broken off of any of the instruments and no adverse affect to the patient and the surgeon does not want to be contacted.There is no further information available.No surgical delay.
Additional 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.

• Brand Name: MBT REVISION REAMER 21MM
• Common Device Name: REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7357303
• Report Number: 1818910-2018-55724
• Device Sequence Number: 13888574
• Product Code: HTO
• UDI-Device Identifier: 10603295096382
• UDI-Public: 10603295096382
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 217863181
• Device Lot Number: A0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/29/2018; 08/13/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/02/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1