MAUDE Adverse Event Report: SYNTHES USA 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.044S

Device Problem Sticking (1597)

Patient Problem Sedation (2368)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 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 two (2) guidewires became bound in a stepped drill bit, and there was difficulty removing the connecting screw from the nail and the insertion handle during a trochanteric fixation nail-advanced (tfna) surgery on (b)(6) 2015.During the surgery, the guide wire for the helical blade was inserted through the guide in normal fashion.The wire was measured and a 10mm tapered drill bit was used to perforate the lateral cortex.The stepped drill bit was then set to the correct length and drilled over guide wire.During this, the guide wire was driven out of femoral head and into the acetabulum.The guide wire remained bound in the stepped drill bit.When stepped drill bit was removed, the surgeon lost reduction and had to re reduce and put in another guide wire and perform the previous steps.When inserting stepped drill but, the guide wire became bound again and was driven 50% into the pelvic ring.The surgeon then removed the guide pin quickly and consulted general surgery to check for any damage to the bladder or colon.No known problems were immediately recognized (follow-up review is planned).Due to the risk of driving the pin any further into pelvis, the surgeon stepped reamed and inserted the helical blade without the guide wire.Subsequent to this event, when the surgeon attempted to disconnect the nail from the insertion handle, the surgeon experienced great difficulty unscrewing the cannulated connecting screw from the nail.The screwdriver was reportedly slipping in the connecting screw.It was able to be removed without additional intervention.There was no known harm to patient and the surgery was successfully completed.There was a total delay of thirty minutes.This is report 7 of 8 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: 5354142
• MDR Text Key: 35414266
• Report Number: 2520274-2016-10111
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• 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: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.044S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• 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: 73 YR
• Patient Weight: 75