MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SP2 MI DISTAL FEM CUTTING BLK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	9505-01-035
Date of Event	07/30/2020
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 teeth are worn and block doesn't stay in the jig well.Send replacement sos to wnc office.No additional information.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.The reported device code material twisted/bent is being retracted since it was incorrectly submitted in the initial medwatch.

• Brand Name: SP2 MI DISTAL FEM CUTTING BLK
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10374736
• Report Number: 1818910-2020-17718
• Device Sequence Number: 11466545
• Product Code: NJL
• UDI-Device Identifier: 10603295224372
• UDI-Public: 10603295224372
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/30/2020

1 Device 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: 9505-01-035
• Device Catalogue Number: 950501035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/20/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No