MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI AP KEEL OSTEOTOME; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Catalog Number	202446010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.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 all polyosteotome was found broken upon cleaning up.

• Brand Name: SIGMA HP UNI AP KEEL OSTEOTOME
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8230959
• Report Number: 1818910-2019-80283
• Device Sequence Number: 215943
• Product Code: HWM
• UDI-Device Identifier: 10603295083160
• UDI-Public: 10603295083160
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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 Catalogue Number: 202446010
• Device Lot Number: GM0709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1