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

Model Number 2440-00-510

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Usfda mdr determination: no reported patient harm due to the 5 minute surgical delay.Additional follow up is being conducted to clarify if the reamer handle would or wouldn't assemble correctly and also to clarify if the reamer handle is what caused the noted debris.The reamer handle is being reported at this time.If/when additional information is received the pc will be updated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reamer snapped whilst surgeon reaming, nurse believed it was caused by the reamer driver handle.Broke into several pieces.Fragments removed from patient.Correct use of the device was observed.Debris in acetabulum all which was removed.Surgical delay of 5 minutes.

Manufacturer Narrative

Product complaint #
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> (b)(4) updated the following sections due to receipt of additional information: b4, d1, d2a, d4, h4, and h6 depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: the instrument associated with this report was not returned.Depuy-synthes 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: QUICKSET ACE GRATER HEAD 47MM
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11337545
• MDR Text Key: 232184868
• Report Number: 1818910-2021-03133
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123798
• UDI-Public: 10603295123798
• 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,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2440-00-510
• Device Catalogue Number: 244000547
• Device Lot Number: SO2000833
• Date Manufacturer Received: 04/26/2021
• Patient Sequence Number: 1