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 Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no patient involvement.It is unknown when device became damaged.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review has been requested.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 during a routine inspection of instruments on (b)(6) 2018, it was noted that on the rod introduction pliers, its ratchet does not hold during loading according to a note on the device, and the pliers might be bent.There were no procedure and patient involvement.This report is for a rod introduction pliers for side-opening implants.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Corrected data: number of parts in complaint.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 during a routine inspection of instruments on august 30, 2018, it was noted that it was noted that the following instruments were found to have device issues.On the first rod introduction pliers for side-opening implants, its set screw in the part that slides up and down the tube is not long enough to keep it in the track.On the second rod introduction pliers, its ratchet does not hold during loading according to a note on the device, and the pliers might be bent.There were no procedure and patient involvement.This report is for a rod introduction pliers for side-opening implants.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Part: 388.50; synthes lot: a7qa10; release to warehouse date: week 10 in 2007; manufacture site: (b)(4); part expiration date: n/a; list of nonconformance¿s: n/a the dhr is no longer available due to the age of the instrument (over 11 years old).The customer reported the ratchet would not hold.The item passed testing per the inspection sheet and worked within normal parameters.The complained issue was not able to be reproduced.The cause of the complained issue is unknown.The item passed synthes final inspection on september 21, 2018 and will be returned to the customer upon completion of the service and repair process.Service record router completed.Finalized service record will be archived in document management system.The evaluation was unconfirmed.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 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: 7903326
• MDR Text Key: 121565838
• Report Number: 2939274-2018-53923
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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: A7QA10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1