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 Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
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
Flexible drill chuck would not hold drill.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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.

• 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: 10835977
• Report Number: 1818910-2020-24539
• Device Sequence Number: 4246646
• Product Code: HTW
• UDI-Device Identifier: 10603295109105
• UDI-Public: 10603295109105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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
• Device Lot Number: AG1299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1