MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 16MM; KNEE INSTRUMENT : REAMERS

Model Number	2178-63-176
Medical Device Problem Codes	Material Twisted/Bent (2981); Naturally Worn (2988)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	06/18/2020
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 end of size 16 reamer is rounded off, due to wear would not stay connected to the adapter.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: update 10-aug-2020: the investigation was re-opened upon the receipt of the product.Examination of the returned device confirmed the reported event.The investigation attributed the root cause to normal use and servicing and 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 will be re-opened as necessary.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: MBT REVISION REAMER 16MM
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10217693
• Report Number: 1818910-2020-14794
• Device Sequence Number: 19470908
• Product Code: HTO
• UDI-Device Identifier: 10603295096337
• UDI-Public: 10603295096337
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/18/2020

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: 2178-63-176
• Device Catalogue Number: 217863176
• Device Lot Number: A1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 08/04/2020; 08/10/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/05/2020; 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR