MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 47MM; HIP INSTRUMENTS : REAMERS

Model Number 2440-00-547

Device Problems Failure to Cut (2587); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

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

Surgeon has indicated several common acetabular grater head reamers in multiple sets (4 each of sizes 47mm-57mm) are dull and worn down due to normal wear and tear (reaming) over an extended period of time and no longer cut into the bone as efficiently.No surgical delay or patient issues.Surgeries all completed successfully.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: "the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: QUICKSET ACE GRATER HEAD 47MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11562769
• MDR Text Key: 242044331
• Report Number: 1818910-2021-05979
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123941
• UDI-Public: 10603295123941
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2440-00-547
• Device Catalogue Number: 244000547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1