MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 52MM; HIP INSTRUMENTS : REAMERS

Model Number 2440-00-552

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem Not Applicable (3189)

Event Date 01/30/2020

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

They have in consignment 9 stem instrument sets and 6 acetabular instr sets,as they have been waiting for 3 more new acetabular instr sets since (b)(6) 2019.In the meantime, we have left 2 sets of acetabular instruments from oc in order to cover those busy days.They opened those 2 loaners yesterday, and for both of them,the surgeons just could not do the reaming as they said the reamers were totally dull.They had to open zimmer acetabular instruments to finish their surgeries.

Manufacturer Narrative

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.H10 additional narrative: added : h6.Corrected : h3.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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.Johnson & johnson canada reported that reamers are dull.Examination of the returned instrument confirmed the complaint of dullness.The complaint sample consisted of (1) quickset ace grater head 52mm, lot so2011736 a search of as400 indicated that this device was distributed for use on 25 sep 2013.A search of the complaint database found similar reports and the root cause is attributed to heavy use and wear out.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under sep 419 post market surveillance.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, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4), 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.Addded d4 (lot/expiration) and d10 corrected: h3.

• Brand Name: QUICKSET ACE GRATER HEAD 52MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9729340
• MDR Text Key: 190660745
• Report Number: 1818910-2020-05363
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123996
• UDI-Public: 10603295123996
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2440-00-552
• Device Catalogue Number: 244000552
• Device Lot Number: SO2011736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1