MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLC FLEX DRILL SHAFT; DRILLS (BITS, SLEEVES, GUIDES) : DRILL/DRIVER SHAFTS

Model Number	2274-20-000
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2020
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
The primary surgery was performed on (b)(6) 2020 via tha for the patient's left hip joint.It was reported that during the surgery, after setting a cup, when the surgeon drilled for screw, the drill bent.Then, the surgeon used another drill (manufactured by (b)(6)), but the drill shaft was crashed.The surgeon completed the surgery with another duraloc drill within 30 minutes delay.The surgeon already had check surgical field and had check by x-ray, he don't think any fragment in the body.However, just to be sure, he requested the investigation for confirming no piece in the body.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Please clarify what do you mean by crashed.Was it broken or cracked?: answer: it was reported that it was flatted.

• Brand Name: DLC FLEX DRILL SHAFT
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILL/DRIVER SHAFTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11126042
• Report Number: 1818910-2021-00514
• Device Sequence Number: 14444621
• Product Code: HTW
• UDI-Device Identifier: 10603295109105
• UDI-Public: 10603295109105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2020

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: 2274-20-000
• Device Catalogue Number: 227420000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 03/16/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/18/2021; 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1