MAUDE Adverse Event Report: SYNTHES USA 2.0MM THREADED GUIDE WIRE 230MM; WIRE, SURGICAL

Catalog Number 292.65

Device Problem Material Fragmentation (1261)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Additional product code: jdw.(b)(4).Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 during an ankle arthrodesis on (b)(6) 2016 when the surgeon was using a drill for the guide wire that the coating on the guide wire was chipping off.The facility started using new drills (non-synthes) and this was never an issue prior to the new drills.It is confirmed that coating that came off was not retained in the patient.There was no surgical delay or patient harm.Surgery was completed successfully.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

It was noted that the device was chipping during the surgical procedure on (b)(6) 2016.As a notation was made that none of the fragments were retained, an event date for the ¿chipping¿ has been added to the associated medwatch field.Product investigation summary: one (1) 2.0mm threaded guide wire 230mm (part 292.65 / lot unknown) was received with complaint category "malformed: nicked/gouged/chipped.¿ this complaint is confirmed as the returned guide wire was received with areas of black coating worn off.The wear pattern is indicative of a drill bit being driven under power and contacting the returned guide wire intermittently while rotating.This occurrence would, thereby, create the intermittent spiral wear pattern.Replication of this complaint was not possible as the drill bit and "new drill" referenced in the complaint description were not returned with the guide wire.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The relevant drawing was reviewed during this evaluation.The guide wire was made from 316l stainless steel and colored black with either titanium carbonitride or aluminum titanium nitride.Because the lot on the returned device is unknown, the exact coating on the returned device cannot be determined.No product design issues or discrepancies were observed during this evaluation.No new, unique, or different patient harms were identified as a result of this evaluation.The design is adequate for its intended use when used and maintained as recommended; it did not contribute to the complaint condition.Device 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: 2.0MM THREADED GUIDE WIRE 230MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5598741
• MDR Text Key: 43348718
• Report Number: 2520274-2016-12231
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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