MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 65MM; HIP INSTRUMENTS : REAMERS

Catalog Number 244000565

Device Problem Material Erosion (1214)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

Instrument is rusty.

Manufacturer Narrative

(b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy considers the investigation closed at this time.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 65MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-XXXX ; 6103142063
• MDR Report Key: 8071393
• MDR Text Key: 127166708
• Report Number: 1818910-2018-75525
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295124122
• UDI-Public: 10603295124122
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 244000565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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