MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US IN-CONDL CHISEL 8X10X7 3/4 IN; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Catalog Number	242101000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device revealed chipping.The investigation findings did not indicate that a broader investigation or corrective action was necessary.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
It was reported that the end of the osteotomes are beat up.Needs replacement, surgery was not delayed and nothing was left in patient.

• Brand Name: IN-CONDL CHISEL 8X10X7 3/4 IN
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9161808
• Report Number: 1818910-2019-107976
• Device Sequence Number: 2112950
• Product Code: FZO
• UDI-Device Identifier: 10603295122715
• UDI-Public: 10603295122715
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/22/2019

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: 242101000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1