MAUDE Adverse Event Report: SYNTHES USA 2.8MM GUIDE WIRE WITH FLUTES 300MM/150MM CALIBRATION; WIRE, SURGICAL

Catalog Number 292.81

Device Problem Break (1069)

Patient Problems Sedation (2368); Device Embedded In Tissue or Plaque (3165)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Device broke intra-operatively and was not implanted / explanted 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 there were two (2) device malfunctions that occurred during a subtrochanteric femur fracture repair using a trochanteric fixation nail advanced (tfna) on (b)(6) 2016.During the reaming process the tip of the reamer (drill bit) broke into two (2) pieces towards in distal end in the patient's femoral neck.It was reported the patient had hard bone in the femoral head and necrosis.The fragment was removed successfully with a 15 minute delay reported in retrieving the fragment.A back up reamer set was available, however, the surgeon decided to use a screw set cannulated reamer to finish reaming the bone.A 2.8mm guide wire was placed in and during the drilling the drill head caught the guide wire and caused the guide wire to break.Approximately 3 cm was left in the bone and was not retrievable.The surgeon then went back to utilize the back-up reamer set and completed the reaming process.A short nail was implanted and the lag screw was able to be implanted.No additional surgical/medical intervention was required.The procedure was completed successfully and the patient is reported to be stable.A combined total of 30 minutes was noted as surgical delay.(b)(4).

• Brand Name: 2.8MM GUIDE WIRE WITH FLUTES 300MM/150MM CALIBRATION
• Type of Device: WIRE, SURGICAL
• 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: 5466714
• MDR Text Key: 39247826
• Report Number: 2520274-2016-11368
• 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: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91