MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET 3.8 DIMTR DR BIT 70MM; HIP INSTRUMENTS : DRILLS

Catalog Number	227459000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Pinnacle/corail hip replacement; a malone, (b)(6) hospital, (b)(6) 2018.During the operation a screw was required, when drilling for a screw the drill bit broke, all parts appear to have been removed from the patient, the procedure was finished with a shorter drill from the set.Patient appears to be ok.1 minute delay to the procedure.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The instrument associated with this report was not returned.Depuy considers the investigation closed at this time.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 will be filed as appropriate.

• Brand Name: QUICKSET 3.8 DIMTR DR BIT 70MM
• Common Device Name: HIP INSTRUMENTS : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7942251
• Report Number: 1818910-2018-71572
• Device Sequence Number: 931167
• Product Code: HTW
• UDI-Device Identifier: 10603295109341
• UDI-Public: 10603295109341
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• 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: 227459000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1