MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MBT REV PRIMARY CONICAL REAMER

Catalog Number	217863199
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
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 connection side of the mbt rev primary reamer was stripped and needs to be replaced.It would not stay connected to the adapter.
Additional Manufacturer Narrative
Product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned device confirmed the reported damage.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 = > null device history batch = > null device history review = > null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REV PRIMARY CONICAL REAMER
• Common Device Name: CONICAL REAMER
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7063822
• Report Number: 1818910-2017-50310
• Device Sequence Number: 155919
• Product Code: HTO
• UDI-Device Identifier: 10603295096535
• UDI-Public: 10603295096535
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 11/01/2017

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: 217863199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/05/2017; 03/09/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 12/11/2017; 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1