MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ANTEVERSION OSTEOTOME MED; HIP INSTRUMENTS : CUTTING INSTRUMENTS

Catalog Number 200225000

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

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 Description

It was reported that a loads of complaints mainly received from (b)(6), this was about the quality of the metal of the box osteotomes.The constant complaints about them being blunt and risking a calcar fracture.

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : the instrument associated with this report was not returned.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: ANTEVERSION OSTEOTOME MED
• Type of Device: HIP INSTRUMENTS : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7684950
• MDR Text Key: 113874445
• Report Number: 1818910-2018-64358
• Device Sequence Number: 1
• Product Code: HWM
• UDI-Device Identifier: 10603295080770
• UDI-Public: 10603295080770
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200225000
• Device Lot Number: SO2010983
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1