MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUN LTL CEM KEEL PUNCH SZ3-5; TIBIAL KEEL PUNCH/BULLET

Catalog Number	254500353
Medical Device Problem Codes	Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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
Upon inspection, cpd noticed wear on the teeth on keep punch.

• Brand Name: ATTUN LTL CEM KEEL PUNCH SZ3-5
• Common Device Name: TIBIAL KEEL PUNCH/BULLET
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9397172
• Report Number: 1818910-2019-119083
• Device Sequence Number: 1699420
• Product Code: JWH
• UDI-Device Identifier: 10603295445661
• UDI-Public: 10603295445661
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• 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 Catalogue Number: 254500353
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1