MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QR DRILL BIT 3.2MMX127MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Catalog Number	255589000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
The reported device was used for the drilling with 3.2mm drill (p/n and lot number were unknown) during the surgery (date of the surgery was unknown).It was reported that the drill was stuck with reported cutting guide, so that the drill could not be come off.The surgeon removed the cutting guide together with stuck drill to complete the surgery.It was brand new and the first use when the issue occurred.There was no harm to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QR DRILL BIT 3.2MMX127MM
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7933991
• Report Number: 1818910-2018-71289
• Device Sequence Number: 16336061
• Product Code: HTW
• UDI-Device Identifier: 10603295142652
• UDI-Public: 10603295142652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: 255589000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1