MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 PROXIMA MI CALCAR REAMER SMALL; HIP INSTRUMENTS : REAMERS

Model Number 9400-80-007

Device Problem Dull, Blunt (2407)

Patient Problem No Code Available (3191)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Us-fda mdr reportability determination complaint review: it was reported that there was a two minute surgical delay for opening another set of instruments, and there was no patient consequence or injury.(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

During a total hip replacement, the surgeon found that the corail size 12 broach did not lock well into the broach handle, nor the corail neck trial.Upon inspection, it looks like the broach connection is slightly burred, causing the issue.There was a 2 minute delay in surgery until nurses could open up another set of corail broaches.Also, the surgeon made a comment of how he thought the calcar reamer was dull and asked that it be replaced.The surgery finished as planned and there was no patient consequence.The broach and calcar reamer will be returned for a replacement.

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.H10 additional narrative:  added: d4 (lot), d9, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.

Manufacturer Narrative

Product complaint # : pc-(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.

• Brand Name: PROXIMA MI CALCAR REAMER SMALL
• Type of Device: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10613179
• MDR Text Key: 209379414
• Report Number: 1818910-2020-21341
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295223627
• UDI-Public: 10603295223627
• 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
• Report Date: 09/18/2020

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: 9400-80-007
• Device Catalogue Number: 940080007
• Device Lot Number: AB3902130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 12/10/2020; 01/28/2021
• Supplement Dates FDA Received: 12/09/2020; 12/23/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1