MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION T-HANDLE; KNEE INSTRUMENT : HANDLES

Model Number	2178-63-137
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
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 two reamers from the mbt reamer set are starting to show wear on the connection end.The t-handle and modified hudson adapter are also showing signs of rounding out on the connection end.No surgical delay.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the submitted device confirming the reported event.The investigation attributed the root cause of the event to device damage/wear from normal use and servicing and the need for corrective action was not indicated.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: d9 corrected: h3.

• Brand Name: MBT REVISION T-HANDLE
• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11247647
• Report Number: 1818910-2021-02028
• Device Sequence Number: 14384264
• Product Code: LXH
• UDI-Device Identifier: 10603295096269
• UDI-Public: 10603295096269
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 2178-63-137
• Device Catalogue Number: 217863137
• Device Lot Number: NB122003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR