MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 PAT PLANER BODY MED; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	976750
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
Sigma patella planing instrument jammed and requires replacement.Csss de laval, (b)(4).Patient consequence? no.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: SP2 PAT PLANER BODY MED
• 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: 7822872
• Report Number: 1818910-2018-67927
• Device Sequence Number: 13752508
• Product Code: HTZ
• UDI-Device Identifier: 10603295251484
• UDI-Public: 10603295251484
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 976750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention