MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PAT/FEM SZ 3-10 DRILL; ATTUNE INSTRUMENTS : PATELLA/FEMORAL DRILLS

Catalog Number	254500049
Medical Device Problem Codes	Device-Device Incompatibility (2919); Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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
It was reported that the patella clamp does not grip tight enough when using the clamp and patella drill bit.
Additional Manufacturer Narrative
Investigation summary the device associated with this report was not returned for evaluation.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 considers the investigation closed at this time.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, 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 evaluation of the returned patella/femoral drill, the flutes are worn form normal use.The drill would not have contributed to the reported event.

• Brand Name: ATTUNE PAT/FEM SZ 3-10 DRILL
• Common Device Name: ATTUNE INSTRUMENTS : PATELLA/FEMORAL DRILLS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7956245
• Report Number: 1818910-2018-72163
• Device Sequence Number: 16376425
• Product Code: HWE
• UDI-Device Identifier: 10603295396154
• UDI-Public: 10603295396154
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2018

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: 254500049
• Device Lot Number: NG56363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 12/04/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/05/2018; 01/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR