MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS; PLIERS,SURGICAL

Model Number 388.50

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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 on (b)(6) 2019 prior to start a posterior spinal fusion procedure, the scrub technician could not place a universal spinal system (uss) titanium (ti) collar onto the uss rod introduction pliers.After looking at the tube on the uss rod introduction pliers, it was discovered that the tube was bent (oblong).Another instrument was available for use prior to the surgery there was no patient involvement.Concomitant device reported: uss ti collar ( part# 498.010, lot# unknown, quantity 1).This report is for one (1) rod introduction pliers for side-opening implants.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Concomitant medical products: device received at the final destination.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part number: 388.50.Lot number: t134820.Manufacturing site: tuttlingen.Release to warehouse date: 26-oct-2016.A review of the device history records was performed for the finished device lot number and a nonconformance was started for the subcomponent 208.0319 because the diameter ø8,90 +0,05 was too small (was 8,89).The lot was checked 100% and the parts were scrapped.The ncs have no impact on the complaint issue.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The final quality release criteria were met before this batch was released for distribution.Visual inspection: the rod introduction pliers for side-opening implants (p/n: 388.50, lot #:t134820) was returned and received.Upon visual inspection, it was observed that the spring was bent.No other issues were identified with the returned components of the device.Device failure/ defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Service & repair evaluation: the customer reported the device was bent.The repair technician reported the device spring was bent.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed rod introduction forceps for side opening implants complaint confirmed? yes, the device received was bent.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the rod introduction pliers for side-opening implants (p/n: 388.50, lot #:t134820).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS
• Type of Device: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9227004
• MDR Text Key: 194461111
• Report Number: 2939274-2019-61722
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10705034773292
• UDI-Public: (01)10705034773292
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 388.50
• Device Catalogue Number: 388.50
• Device Lot Number: T134820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6.0MM TI COLLAR