MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 DISTAL FEM CUTTING BLOCK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	96-6115
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
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
Match issue.It was reported that as the event (b)(4) happened, considering safety, the distributor checked the same lot products, noted the impact product also with the same issue: 966112 could not pass the way through the slot/hole of 966115.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirms the reported event.Root cause and corrective action are documented in the capa system.Depuy considers the investigation closed.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) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added d11 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10039647
• Report Number: 1818910-2020-11909
• Device Sequence Number: 11497384
• Product Code: HAW
• UDI-Device Identifier: 10603295246862
• UDI-Public: 10603295246862
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2020

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: 96-6115
• Device Catalogue Number: 966115
• Device Lot Number: SO2040602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 07/22/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 07/01/2020; 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SP*2 FEM LOCATG DEV OUTRIGGER