MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2 MOD TIB DRL NP15MM SZ4-6; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number	96-6381
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Event or Problem Description
It was reported that on (b)(6) 2020, the surgeon noticed that our size 4-6 cemented tibial drill was dull and needed to be sharpened.The drill did work for the case but needs to be replaced.The two drills being returned are complete and had no pieces that broke off of it.No surgical delay.On (b)(6) 2020 - 2 devices were received for investigations.

• Brand Name: SP2 MOD TIB DRL NP15MM SZ4-6
• 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: 11055561
• Report Number: 1818910-2020-27438
• Device Sequence Number: 11822661
• Product Code: HWE
• UDI-Device Identifier: 10603295248231
• UDI-Public: 10603295248231
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 12/08/2020

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: 96-6381
• Device Catalogue Number: 966381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1