MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TAPERED CEMENT REAMER; KNEE INSTRUMENT : REAMERS

Model Number	2178-63-106
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
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 hudson adapter was stripped.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed the attachment end to be stripped.The damage is consistent with device wear out through normal use and servicing and the investigation did not establish a need for corrective action.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.

• Brand Name: MBT REV TAPERED CEMENT REAMER
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9764657
• Report Number: 1818910-2020-06238
• Device Sequence Number: 2456047
• Product Code: HTO
• UDI-Device Identifier: 10603295096054
• UDI-Public: 10603295096054
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Model Number: 2178-63-106
• Device Catalogue Number: 217863106
• Device Lot Number: A0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR