MAUDE Adverse Event Report: SYNTHES USA 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM; APPLIANCE, FIXATION, NAIL

Catalog Number 292.68

Device Problem Device Abrasion From Instrument Or Another Object (1387)

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

Event Date 01/07/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Full common device name: appliance, fixation, nail/blade/plate combination, multiple component, metal composite.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 subtalar fusion, the surgeon was having difficulty with the 2.8mm threaded guide wire-trocar point 300mm as the collet (non-synthes) was slipping and scored the wire.This occurred after the joint surface was prepped, before the screws were implanted.There was a surgical delay of an unknown duration.The procedure was completed successfully with no patient harm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.The returned product was evaluated by the manufacturer and it was determined that the complaint condition was able to be confirmed as the shaft of each is severely damaged (scratched/scored).Based on the complaint description the condition of the received wires is the result of a non-synthes¿ product malfunctioning during insertion.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.Review of the attached history shows no similar events.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

The initial complaint was reviewed and found not reportable.The returned product was evaluated by the manufacturer and it was determined that the complaint condition was able to be confirmed as the shaft of each is severely damaged (scratched/scored).Based on the complaint description the condition of the received wires is the result of a non-synthes product malfunctioning during insertion.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.Review of the attached history shows no similar events.

• Brand Name: 2.8MM THREADED GUIDE WIRE- TROCAR POINT 300MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5382416
• MDR Text Key: 36464739
• Report Number: 2520274-2016-10357
• Device Sequence Number: 1
• Product Code: LXT
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

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: 292.68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1