MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TAPERD PRESSFIT REAMER; KNEE INSTRUMENT/TRIAL

Catalog Number	217863104
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reamers do not work well; the coupling system to the drill does not work.Revision b reamers (products d 217863106 and d 217863104) must be replaced.
Additional Manufacturer Narrative
The device associated with this reported event was not received for evaluation.Depuy considers the investigation closed.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 REV TAPERD PRESSFIT REAMER
• Common Device Name: KNEE INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6864321
• Report Number: 1818910-2017-24573
• Device Sequence Number: 107972
• Product Code: HTO
• UDI-Device Identifier: 10603295096047
• UDI-Public: 10603295096047
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 08/15/2017

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: 217863104
• Device Lot Number: A0110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR