MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRIVER EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number	2046-10-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the instrument associated with this report was not returned.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.
Event or Problem Description
Explant infected total hip implants and insertion prostalac antibiotic spacer.Explanted implants: corail collarless stem, 36, 1.5mm delta ts head, 36x52, +4 neutral liner.1 bone screw, pinnacle 52mm sector cup.

• Brand Name: DRIVER EXTRACTOR
• Common Device Name: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10137600
• Report Number: 1818910-2020-13537
• Device Sequence Number: 17053130
• Product Code: HWB
• UDI-Device Identifier: 10603295084365
• UDI-Public: 10603295084365
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: 2046-10-000
• Device Catalogue Number: 204610000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR