MAUDE Adverse Event Report: SYNTHES USA 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL

Catalog Number 292.620

Device Problems Break (1069); Overheating of Device (1437)

Patient Problems Burn(s) (1757); Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Additional product code: hty.Udi: (b)(4) lot unknown.Implant and explant dates: device broke during insertion; device not considered implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter phone number: (b)(4).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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that two threaded needles broke in the patient foot bone due to issues with the kirschener wire attachment and the drill attachment.The broken devices remained in the patient and it was noted that the devices also overheated and burned the patient¿s bone.There was an increase in surgical time by twenty (20) minutes.It was noted that the drill bit did not have cutting edge; this drill was completely rusted and uncut and had been used several times.The procedure was completed with spare non-synthes power tool equipment.There was no intervention to try to remove the broken devices from the patient¿s bone.The patient¿s current status is unknown.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the complained parts were not returned for investigation so an investigation was completed on the provided pictures.According to received pictures, both k-wires (part 292.620) were broken.The attachment was not able to hold the k-wire properly, which most probable caused breakage of the wires.The root cause of the problem is improper handling.The device has not been annually serviced and the device history record and service history record review does not reveal any relevance to the current complaint condition.According to received pictures, a lot of signs of the corrosion are visible on the drill bit (part 310.670) and the cutting edges do not exist anymore.Most probable the drill bit was already worn (used too many times) and incorrectly reprocessed.Cutting tools are frequently exposed to high mechanical loads and shocks during use and should not be expected to last indefinitely.Using worn out cutting tools like the reported one generates a lot of heat.The root cause of the problem is normal wear and improper reprocessing, the device has not been annually serviced and the device history record and service history record review does not reveal any relevance to the current complaint condition.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: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6232481
• MDR Text Key: 64170648
• Report Number: 2520274-2017-10077
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 68