MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 3.8 DIMTR DR BIT 70MM; HIP INSTRUMENTS : DRILLS

Model Number	2274-59-000
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 surgeon; port macquarie base hospital (b)(6) 2020; two drill bits broken using case also drill bits blunt.Action taken to manage the issue: single use smith and nephew drill bit used - competitor single use product used.10 minute delay to the procedure, no ae to patient.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.H10 additional narrative: added: e1 (facility name).Corrected: h6 (patient).H6 patient code: removed the code for not applicable and replaced with no code available (3191) to capture prolonged surgery and insufficient information.

• Brand Name: QUICKSET 3.8 DIMTR DR BIT 70MM
• Common Device Name: HIP INSTRUMENTS : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10193301
• Report Number: 1818910-2020-14406
• Device Sequence Number: 3408864
• Product Code: HTW
• UDI-Device Identifier: 10603295109341
• UDI-Public: 10603295109341
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: 2274-59-000
• Device Catalogue Number: 227459000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR