MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPL F/6.0MM RODS; PLIERS,SURGICAL

Model Number 388.509

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device history records review not available to report at this time.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 one (1) table top rod cutter and bender had a lot of resistance, causing a rod to not pass in and out through the holes in the cutter, and one (1) rod introduction pliers for dual-opening implants for 6.0 mm rods caused the scrub technicians a hard time loading an implant on it during a spinal fusion procedure on (b)(6) 2018, and subsequently, the handle on the pliers fell off at an unknown time.The scrub technicians were training a new recruit during a surgery when they loaded an unknown collar on the pliers and the pliers did not hold the collar as intended, giving the scrub technicians a hard time.Subsequently, the handle on the pliers was found to have fallen off after cleaning in the sterile processing department (spd) and it is unknown if the handle fell off during the surgery or during the cleaning process.Another set of pliers and cutter/bender were available at the time of the surgery and hence there was no surgical delay.The procedure was reported to have been completed successfully and without any complications.The patient condition was reported to have been stable.This complaint involves one (1) instruments.Concomitant devices reported: unknown collar (part# unknown, lot# unknown, quantity# 1); unknown 6.0 mm rods (part# unknown, lot# unknown, quantity# unknown).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 388.509, lot# a7na31.Manufactured by: (b)(4), manufacturing date: aug 26, 2004.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service and repair evaluation was completed.The customer reported the handle of the pliers fell off after it was difficult to load the implant.The repair technician reported the spring and ratchet were worn.Worn out parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: spring (set), ratchet.The item was repaired per the inspection sheet, passed synthes final inspection on 6-apr-2018 and will be returned to the customer upon completion of the service and repair process.The device was deemed serviceable and 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.

Manufacturer Narrative

Device history records review was completed for part# 388.509, lot# a7na31.Manufactured by: (b)(4), manufacturing date: aug 26, 2004.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Service and repair evaluation was completed.The customer reported the handle of the pliers fell off after it was difficult to load the implant.The repair technician reported the spring and ratchet were worn.Worn out parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: spring (set), ratchet.The item was repaired per the inspection sheet, passed synthes final inspection on 6-apr-2018 and will be returned to the customer upon completion of the service and repair process.The device was deemed serviceable and 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 DUAL-OPENING IMPL F/6.0MM RODS
• 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: 7424085
• MDR Text Key: 105569409
• Report Number: 2939274-2018-51604
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10705034773339
• UDI-Public: (01)10705034773339(10)A7NA31
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 388.509
• Device Catalogue Number: 388.509
• Device Lot Number: A7NA31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1