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 Compatibility Problem (2960)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device was 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) 2020, the patient underwent a scoliosis t10-l5 fusion procedure.Upon inspection, during setup, it was noticed that the handles of two (2) socket wrench with straight handle (with silicone handle) had a residue of white powder in the cannula resulting in the entire sterile field being contaminated.During the surgery, two (2) rod introduction pliers were used and ended up getting stuck inside a hook/screw holder and the handle of a socket wrench with straight handle disintegrated upon routine tightening.The procedure was successfully completed with a thirty (30) minute surgical delay.The patient's status is unknown.Concomitant device reported: unknown nut (part#: unknown, lot#: unknown, quantity: 1) this report is for one (1) rod introduction pliers for side-opening implants.This is report 2 of 3 for (b)(4).

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.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.Service and repair history: the previous service event for part number 388.50 with lot number(s) t124099 has been reviewed.The customer called in a service request for this item on oct 22, 2020 for handles of two (2) socket wrench with straight handle (with silicone handle) had a residue of white powder in the cannula.The item was previously returned for service on (b)(6) 2018 due to tube burred at slot.The previous service condition of tube burred at slot is not relevant to the current complained issue of handles of two (2) socket wrench with straight handle (with silicone handle) had a residue of white powder in the cannula.The manufacture date of this item is dec 29, 2015.The service history review is unconfirmed.Service and repair evaluation: the repair technician reported the collet and tube were loose.Loose component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: tube, nut, collet, and all applicable components.The item was repaired per the inspection sheet, passed synthes final inspection on nov 12, 2020 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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: 10868354
• MDR Text Key: 217452283
• Report Number: 2939274-2020-05223
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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: T124099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HOOK OR SCREW HOLDER; ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS; SOCKET WRENCH WITH STRAIGHT HANDLE-11MM WIDTH; SOCKET WRENCH WITH STRAIGHT HANDLE-11MM WIDTH; SOCKET WRENCH WITH STRAIGHT HANDLE-11MM WIDTH; UNK - NUTS