MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM ASSEM UPPER PULL ROD; RECLAIM INSTRUMENTS : INSERTION DEVICES

Model Number 2975-00-635

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Visual exam found the threaded end is stripped and will not properly engage with mating device.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.

Event Description

It was reported that the assembly tool for attaching proximal body to the stem would not engage or work correctly.Surgeon had to mallet the body onto the stem not able to use the appropriate tensioning bar.A surgical delay of 30 minutes was noted.

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 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: h6 (device) corrected: h6 (patient) h6 patient code: no code available (3191) was used to capture prolonged surgery and insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Type of Device: RECLAIM INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10206087
• MDR Text Key: 196765054
• Report Number: 1818910-2020-14566
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295156017
• UDI-Public: 10603295156017
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2975-00-635
• Device Catalogue Number: 297500635
• Device Lot Number: SO2003220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Date Manufacturer Received: 06/12/2020
• Patient Sequence Number: 1