MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP TIBIAL TRAY HANDLE; KNEE INSTRUMENT : HANDLES

Model Number	9505-02-028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
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 during insertion of the trial tibia into the knee, one connection prong broke off into the trial tibia from the trial tibia base plate handle.All pieces were recovered.No surgical delay.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.The root cause was attributed to user error, 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 will be re-opened as necessary.H10 additional narrative: added: d4 (lot), d10.

• Brand Name: HP TIBIAL TRAY HANDLE
• Common Device Name: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10272276
• Report Number: 1818910-2020-15840
• Device Sequence Number: 14264643
• Product Code: LXH
• UDI-Device Identifier: 10603295227489
• UDI-Public: 10603295227489
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/01/2020

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: 9505-02-028
• Device Catalogue Number: 950502028
• Device Lot Number: J0808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1