MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; MISC ORTHO SURGICAL INSTR

Catalog Number 357.372

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information is available for reporting.Original alert date of complaint was (b)(4) 2018, this device was re-assessed from concomitant to complaint device on february 27, 2017 and was deemed reportable.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history and service evaluations pending.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 an initial tfn implanting procedure on (b)(6) 2018, the bolt (nub) on one (1) helical blade coupling screw broke and its shaft got stuck in the helical blade inserter, thus rendering the helical blade inserter useless.The surgeon was reportedly hammering the helical blade in, when the bolt on the helical blade connecting screw broke, i.E.The connecting screw broke cleanly in two pieces and hence there were no fragments generated.The break caused the shaft of the helical blade connecting screw to be stuck in the helical blade.To uncouple the shaft, a screw removal set was used.The handle on the helical blade inserter had to be removed in order to uncouple the coupling screw.The bolt was stuck in the helical blade inserter, and could not be removed, thus rendering the helical blade inserter useless for future use.The surgery was completed by using the same devices, where the helical blade inserter was used without the handle.There was about five minutes of surgical delay reported.The surgery was reported to be successful after this and the patient was reported to be in stable condition.Concomitant devices reported: unknown mallet (part# unknown, lot# unknown, quantity# 1); unknown tfn helical blade (part# unknown, lot# unknown, quantity# 1).This is report 2 of 2 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device dhr review for part: #357.372 -synthes lot # 6662205.Release to warehouse date:09may2011.Expiration date: na.Made by: synthes (b)(4).No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.A service and repair evaluation was performed for the subject device: the customer reported the coupling screw broken and the shaft got stick in the inserter.The repair technician reported the alignment indicator pin was broken, and the adjustment screw was bent.Damaged component is the reason for repair.The cause of the issue is unknown.The following parts were replaced: replacement alignment.The item was repaired per the inspection sheet, passed synthes final inspection on 27-feb-2018 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 docusphere document management system.The evaluation was confirmed.A service history review could not be performed because the device is a lot/batch controlled item.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: HELICAL BLADE INSERTER
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7309344
• MDR Text Key: 101698136
• Report Number: 2939274-2018-50820
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982196064
• UDI-Public: (01)10886982196064(10)6662205
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.372
• Device Lot Number: 6662205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1