MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM TPD HEX DRIVER; HIP INSTRUMENT/TRIAL

Catalog Number	234601000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the spd found a screwdriver broken after the case.There was no surgery time or patient affected.It was also reported that the replacement screwdriver was found to be stripped.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The reported observation could not be confirmed.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: APEX HOLE ELIM TPD HEX DRIVER
• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7047992
• Report Number: 1818910-2017-29491
• Device Sequence Number: 19249756
• Product Code: HXX
• UDI-Device Identifier: 10603295119715
• UDI-Public: 10603295119715
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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 Catalogue Number: 234601000
• Device Lot Number: AG0904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2018
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1