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

Model Number	2230-00-095
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
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 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.
Additional 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.
Event or Problem 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
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10416883
• Report Number: 1818910-2020-18263
• Device Sequence Number: 17048800
• Product Code: HWT
• UDI-Device Identifier: 10603295103455
• UDI-Public: 10603295103455
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR