MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 STD TB PUNCH GDE SZ 1.5-4; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET

Model Number	96-6350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received for examination, therefore the reported event could not be confirmed.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 meadwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(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
The pin on handle#(b)(4) was broken.Needs to be replaced.

• Common Device Name: KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9398306
• Report Number: 1818910-2019-119156
• Device Sequence Number: 11388004
• Product Code: JWH
• UDI-Device Identifier: 10603295248033
• UDI-Public: 10603295248033
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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 Model Number: 96-6350
• Device Catalogue Number: 966350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1