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

Catalog Number	255589000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned instrument 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 will be filed as appropriate.
Event or Problem Description
It was reported that the reported drill could not drill to fit the cutting guide to the patient¿s bone during artificial shoulder joint replacement surgery on (b)(6) 2018.Also, the drill could not be detached from the cutting guide.The surgery was finished without any other problem although it was not reported how the surgery was completed.It was brand new and the first use when the issue occurred.There was less than 30min.Surgical delay and no harm to the patient.

• Brand Name: QR DRILL BIT 3.2MMX127MM
• 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: 7869264
• Report Number: 1818910-2018-69143
• Device Sequence Number: 19252167
• Product Code: HTW
• UDI-Device Identifier: 10603295142652
• UDI-Public: 10603295142652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NI
• 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
• Report Date (Section B): 08/17/2018

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: 08/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1