MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS CEM PLUG DRILLS 4.5MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number	2108-04-000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
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
Solution drill was bent intra-op whilst surgeon was attempting to use in femoral canal.There was no incident with patient.Instrument was deemed irreparable and a new one was ordered.There is no other information to be obtained.
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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SOL SYS CEM PLUG DRILLS 4.5MM
• 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: 11641278
• Report Number: 1818910-2021-07532
• Device Sequence Number: 2988386
• Product Code: HWT
• UDI-Device Identifier: 10603295086932
• UDI-Public: 10603295086932
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/05/2021

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: 2108-04-000
• Device Catalogue Number: 210804000
• Device Lot Number: A0301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1