MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 48MM; HIP INSTRUMENTS : REAMERS

Model Number 2440-00-548

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/11/2020

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

Surgeon noted that acetabular reamers in sizes 45, 47, 48, 50 were dull due to long term wear.The surgery took longer and more force was required to achieve appropriate reaming of acetabulum.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

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.Additional narrative: .

Manufacturer Narrative

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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Corrected h6 (3191) from no signs and symptoms, no patient consequence to surgery prolonged and no information available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The surgery took longer and more force was required to achieve appropriate reaming of acetabulum.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Patient code ((b)(4)) from surgery prolonged to no signs and symptoms, no patient consequence.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received states that there was no surgical delay.

• Brand Name: QUICKSET ACE GRATER HEAD 48MM
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10428021
• MDR Text Key: 203643393
• Report Number: 1818910-2020-18437
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295123958
• UDI-Public: 10603295123958
• 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,Followup,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2440-00-548
• Device Catalogue Number: 244000548
• Device Lot Number: SO2031169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 08/26/2020; 08/31/2020; 09/24/2020; 10/08/2020; 10/08/2020
• Supplement Dates FDA Received: 08/26/2020; 09/09/2020; 10/07/2020; 10/09/2020; 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1