MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ QC PERIPH BIT; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number 2230-00-095

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

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 when using drill bits on the set the surgeon said that they are too dull and asked that the drill bits that are used on ever cased be exchanged for new ones.No surgical delay.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary:examination of the returned device confirmed the reported event.The instrument appears to have been heavily used.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: b5, d4 (lot).

Event Description

The suggestion was that while the reamer did an adequate job reaming, it required more pressure to accomplish the desired result.Surgeon said that the reamers were dull and all needed to be changed.

• Brand Name: APG+ QC PERIPH BIT
• 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: 10416943
• MDR Text Key: 203316404
• Report Number: 1818910-2020-18260
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295103455
• UDI-Public: 10603295103455
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2230-00-095
• Device Catalogue Number: 223000095
• Device Lot Number: PG1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR