MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 FEM LUG DRILL W/HUD END; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 96-6202

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

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 the lug drill is dulled and not cutting patella trial is missing a peg that sheared off.The size poly trials are faded and sizes aren¿t able to be read or distinguished.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.

• Brand Name: SP2 FEM LUG DRILL W/HUD END
• Type of Device: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10308855
• MDR Text Key: 199893578
• Report Number: 1818910-2020-16535
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10603295247272
• UDI-Public: 10603295247272
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

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 Model Number: 96-6202
• Device Catalogue Number: 966202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1