MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 57MM; HIP INSTRUMENTS : REAMERS

Model Number 2440-00-557

Device Problem Material Deformation (2976)

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

Event Date 09/27/2021

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.Investigation summary: the device associated with this report was returned for analysis and also a photo was provided.Examination of the returned device and photograph, found several marks/scratches related to heavy use.Additionally, the cutting surfaces were noted dull to the touch, not as sharp as first distributed.As reported, one cutting surface was noted broken and with a burr.Few rusted areas were also found, which had been previously attributed to the use of harsh chemical cleaners.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.

Event Description

During routine inspection of instruments by the sterile processing department, it was found the a pinnacle 57mm grater had become deformed at one of the individual grater holes, resulting in a prominent metal burr protruding from the grater.The device was immediately removed from circulation and a request for replacement was submitted.No patient consequences were reported.

• Brand Name: QUICKSET ACE GRATER HEAD 57MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12851078
• MDR Text Key: 281166542
• Report Number: 1818910-2021-25890
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295124047
• UDI-Public: 10603295124047
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2440-00-557
• Device Catalogue Number: 244000557
• Device Lot Number: SO2037013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2018
• 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