MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 MBT REVISION REAMER 20MM; KNEE INSTRUMENT : REAMERS

Catalog Number	217863180
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The connection between the reamer (size 20) and the modified hudson adaptor in the mbt revision set kept coming apart.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary no device was returned.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was returned.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Reopen update (b)(4), 2019: received complaint device.Examination of the returned device confirmed the reported damage.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 20MM
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7960220
• Report Number: 1818910-2018-72321
• Device Sequence Number: 19267210
• Product Code: HTO
• UDI-Device Identifier: 10603295096375
• UDI-Public: 10603295096375
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 217863180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/21/2018; 01/03/2019
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/28/2018; 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1