MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM BOLT TORQ WRENCH HNDL; RECLAIM INSTRUMENTS : WRENCHES

Model Number 2975-00-300

Device Problem Mechanical Problem (1384)

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

Event Date 10/08/2020

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

The reclaim stem system was implanted.During the tightening of the locking bolt as per the surgical technique with the torque limiting handle 2975-00-300, it didn't make an audible click as it should when adequately tightened.We took the torque limiting handle off the pronged stem stabilizer 2975-00-400 and then reattached it just incase it wasn't attached correctly the first time.This still didn't work.The surgeon had said that he had tightened it, but this handle is supposed to click when the correct torque has been applied.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary
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> 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.

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.

• Brand Name: RECLAIM BOLT TORQ WRENCH HNDL
• Type of Device: RECLAIM INSTRUMENTS : WRENCHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10719268
• MDR Text Key: 212539067
• Report Number: 1818910-2020-23083
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10603295155898
• UDI-Public: 10603295155898
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2975-00-300
• Device Catalogue Number: 297500300
• Device Lot Number: SO2005253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1