MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 48MM; HIP INSTRUMENTS : REAMERS

Catalog Number 244000548

Device Problems Crack (1135); Dull, Blunt (2407); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

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 instruments cracked,pitted, and damaged cutting edges on acetabular graters.Graters were sent back to the repairs/sharpening department and were approved for continued use, however the hospital is refusing them.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: the device associated with this complaint 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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: QUICKSET ACE GRATER HEAD 48MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7525352
• MDR Text Key: 108617685
• Report Number: 1818910-2018-59960
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123958
• UDI-Public: 10603295123958
• 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,Followup
• Report Date: 04/19/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 244000548
• Device Lot Number: A0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/19/2018; 07/30/2018; 08/24/2018
• Supplement Dates FDA Received: 07/04/2018; 08/20/2018; 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2010
• 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