MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 51MM; HIP INSTRUMENTS : REAMERS

Catalog Number 244000551

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

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

Event: the product was oxidized.

Manufacturer Narrative

Product complaint #: (b)(4).

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, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICKSET ACE GRATER HEAD 51MM
• 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 US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 7633506
• MDR Text Key: 112302482
• Report Number: 1818910-2018-63032
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123989
• UDI-Public: 10603295123989
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

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: 244000551
• Device Lot Number: SO2027508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 11/30/2018
• Supplement Dates FDA Received: 07/11/2018; 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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