MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIBIAL BROACH 29 MM; KNEE INSTRUMENT : BROACHES

Model Number	2178-63-109
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	09/21/2020
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 product d961673 is worn and needs to be replaced, the black end that goes over the implant to tighten was slipping when the surgeon was putting implants together.Product d217863109 and d217863111 are not holding stem trials well due to the wear at the connection site.Needs to be replaced.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > examination of the returned device confirmed the reported event of wear.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 TIBIAL BROACH 29 MM
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10623941
• Report Number: 1818910-2020-21558
• Device Sequence Number: 14204162
• Product Code: HTQ
• UDI-Device Identifier: 10603295096078
• UDI-Public: 10603295096078
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/21/2020

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: 2178-63-109
• Device Catalogue Number: 217863109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1