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

Catalog Number 388.50

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Device is an instrument and is not implanted/explanted.Dhr review was completed.Part # 388.50 ; synthes lot # 3914478; supplier lot # a7ha29; release to warehouse date: 28jan1999; supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Service and repair conducted an evaluation of the returned device.The customer reported the device was bent and the collar would not fit.Device history record(s) review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Service and repair evaluation: the repair technician reported the tube and collet were bent and damaged.Bent is the reason for repair.The cause of the issue is unknown.The following parts were replaced: tube, nut, collet, dog point set screw.The item was repaired per the inspection sheet, passed synthes final inspection on 27-jun-2018 and will be returned to the customer upon completion of the service and repair process.Conclusion: 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.

Event Description

It was reported that during routine inspection on june 13, 2018, it was discovered that there were malfunctions on five (5) different instruments.The tube of two (2) rod introduction pliers for side-opening implants were discovered bent and the collar would not fit.In addition, it was also noted that the securing pin on the handle for hook/screw holder was starting to come out resulting to not accepting the holder screw.The rod introduction pliers for dual-opening implant was also noted to be broken or cracked.And the threaded holding sleeve for polyaxial screws was also found stripped and did not thread on the screw easily.There was no patient involvement.Concomitant devices reported: unknown collar (part # unknown, lot # unknown, quantity 1), unknown screw holder (part # unknown, lot # unknown, quantity 1), unknown polyaxial screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) rod introduction pliers for side-opening implants.This is report 2 of 2 for (b)(4).

• 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7747962
• MDR Text Key: 116063628
• Report Number: 2939274-2018-53185
• Device Sequence Number: 1
• Product Code: HTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/1999
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1