MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP MBT NONCEM KL PNCH SZ 4-7; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET

Catalog Number	950502015
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
Does not stay on handle.
Additional Manufacturer Narrative
Corrected g4 date.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : the instrument associated with this report was not received for examination.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Corrected b4 date and added the lot number.

• Brand Name: HP MBT NONCEM KL PNCH SZ 4-7
• 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: 9233084
• Report Number: 1818910-2019-111757
• Device Sequence Number: 14074359
• Product Code: LRY
• UDI-Device Identifier: 10603295227359
• UDI-Public: 10603295227359
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2018

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: 950502015
• Device Lot Number: J1009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/23/2019; 10/23/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 10/31/2019; 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1