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

Catalog Number 868801

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 07/05/2018

Event Type  malfunction  

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 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.

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
• Type of Device: KNEE INSTRUMENT : PATELLA/FEMORAL DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7735412
• MDR Text Key: 115564962
• Report Number: 1818910-2018-65510
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295218067
• UDI-Public: 10603295218067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR