MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 46MM; HIP INSTRUMENTS : REAMERS

Model Number 2440-00-546

Device Problems Crack (1135); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported that as per hospital, they feel some of the reamers are cracked.It was not sure if it is just wear and tear from being used so i would like j&j to look over and send report back on their findings.If there is an issue, then will the hospital credit new ones replaced at no charge? there are 4 of the graters that i can not read the lot number.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Examination of the returned device confirmed the complaint.Visual exam found evidence of heavy wear.The cutting teeth are dull and there are areas where the material cracked between the teeth.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.

• Brand Name: QUICKSET ACE GRATER HEAD 46MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10336048
• MDR Text Key: 200800265
• Report Number: 1818910-2020-17091
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123934
• UDI-Public: 10603295123934
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2440-00-546
• Device Catalogue Number: 244000546
• Device Lot Number: SO2010379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1