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

Catalog Number 244000551

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

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

The piece broke before use on patient in preparation for thr surgery.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: the product was returned for examination and the complainants findings confirmed.The grater shell section had detached from the base.The edge of the shell showed signs of excessive wear.The root cause was deemed to be wear and tear.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.Device history lot: null.Device history batch: null.Device history review: null.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 51MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9510936
• MDR Text Key: 184583054
• Report Number: 1818910-2019-124536
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123989
• UDI-Public: 10603295123989
• 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: 12/03/2019

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: A1205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1