MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV REAMER ADAPTER; KNEE INSTRUMENT : ADAPTORS

Model Number	2178-63-128
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
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
It was reported that the proximal reamer won't disconnect from adapter.Therefore the drill stop cannot be taken off as well.Surgery time was not delayed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed the reported event.The investigation did not establish that a broader investigation or corrective action was necessary.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 REAMER ADAPTER
• Common Device Name: KNEE INSTRUMENT : ADAPTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10426554
• Report Number: 1818910-2020-18381
• Device Sequence Number: 16891690
• Product Code: HTO
• UDI-Device Identifier: 10603295096207
• UDI-Public: 10603295096207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/06/2020

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: 2178-63-128
• Device Catalogue Number: 217863128
• Device Lot Number: AH1104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR ADAPTER INSTRUMENT