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

Investigation summary: service and repair evaluation it was reported that on (b)(6) 2020, the patient underwent an unknown 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.It is unknown if there was any surgical delay.The procedure outcome and the patient's status are unknown.The repair technician reported that the set screw dog point was damaged.Damaged component is the reason for repair.The cause of the issue is not determined.The following parts were replaced: set screw dog point.The item was repaired per the inspection sheet, passed synthes final inspection on 11-nov-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 history lot, part number: 388.50, lot number: t134820, manufacturing site: (b)(4), release to warehouse date: oct 26, 2016.A review of the device history records was performed for the finished device lot number and a nc nr-0048652 was started for the subcomponent 208.0319 (work order 134825) because the diameter ¿8,90 +0,05 was too small (was 8,89).The lot were checked for 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.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 1 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.

• 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: 10868282
• MDR Text Key: 217444447
• Report Number: 2939274-2020-05222
• 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
• 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: T134820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• 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