MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 HP MBT CEM KEEL PUNCH SZ 2-3; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET

Catalog Number	950502011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
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
Part broke off.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported breakage.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.

• Brand Name: HP MBT CEM KEEL PUNCH SZ 2-3
• Common Device Name: KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8129596
• Report Number: 1818910-2018-77116
• Device Sequence Number: 267998
• Product Code: LRY
• UDI-Device Identifier: 10603295227311
• UDI-Public: 10603295227311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/07/2018

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: 950502011
• Device Lot Number: NB55529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1