MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC OVAL PAT DRILL W/HUD END; KNEE INSTRUMENT : PATELLA/FEMORAL DRILLS

Catalog Number	868801
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
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
It was reported that patellar drill would not advance thru guide to create peg holes.Drill was swapped out with another one and peg holes were completed without any additional issues."old" patella drill being returned to local office.Surgical delay: 1 minute.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # : (b)(4).Examination of the returned device found no evidence of device malfunction or product error.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PFC OVAL PAT DRILL W/HUD END
• Common Device Name: KNEE INSTRUMENT : PATELLA/FEMORAL DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7735412
• Report Number: 1818910-2018-65510
• Device Sequence Number: 10964026
• Product Code: HWE
• UDI-Device Identifier: 10603295218067
• UDI-Public: 10603295218067
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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
• Report Date (Section B): 07/05/2018

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: 868801
• Device Lot Number: B0707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR