MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. QUICKSET ACE GRATER HANDLE; HIP INSTRUMENT/TRIAL

Catalog Number 244000510

Device Problem Disassembly (1168)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

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 the acetabular grater handles are not springing back into place and the graters are disengaging in the patient.

Manufacturer Narrative

(b)(4).Investigation summary no instrument associated with this report was received for examination.Depuy considers the investigation closed.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.

Event Description

Complaint description: it was reported that the acetabular grater handles are not springing back into place and the graters are disengaging in the patient.

• Brand Name: QUICKSET ACE GRATER HANDLE
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46581
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 5743725905
• MDR Report Key: 6827913
• MDR Text Key: 83895728
• Report Number: 1818910-2017-23638
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123798
• UDI-Public: 10603295123798
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 244000510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1