MAUDE Adverse Event Report: SYNTHES HAGENDORF COMPLETE RADIOLUCENT INSERTION HANDLE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.037.012

Device Problem Sticking (1597)

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

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patients id case number is (b)(6).(b)(4).Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Dhr not attempted/completed.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 surgery on (b)(6) 2015, while treating a subtrochanteric fracture, the locking mechanism of trochanteric fixation nail advance would not advance.When removing the insertion handle to complete the surgery, the cannulated connecting screw would not disengage from the nail.The surgeon made multiple attempts to remove the screw using a t-handle ball hex screwdriver.During this process the ball broke off and was retrieved.The handle was unable to be removed from the nail.The surgeon proceeded to remove all implantable devices (helical blade was damaged in removal) and a second set was used to complete the surgery.There was a surgical delay of approximately 20 minutes.The surgery was successfully completed with no harm to the patient.This report is 2 of 5 for (b)(4).

Manufacturer Narrative

Device history record review: manufacturing site: (b)(4) - manufacturing date: may 13, 2014.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this 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.

Manufacturer Narrative

A product development investigation summary was performed - the insertion handle is still attached to a tfna long nail via the connecting screw.It has no visible signs of damage, but it cannot be removed using a standard ball-hex screwdriver.The insertion handle was included as part of this complaint because the surgeon was unable to remove the connecting screw from the nail.There are no other problems with the insertion handle.When the surgeon attempted to disconnect the insertion handle at the conclusion of the procedure using the ball-hex screwdriver, the connecting screw was so tightly bound that the torque applied to the screwdriver caused the ball to break apart from the shaft.With no other option to remove the connecting screw, the surgeon had to take out the helical blade in order to remove the nail-insertion assembly and try again with a different set.After many attempts to loosen the connecting screw with a screwdriver and wrench in the test lab, the returned nail assembly eventually detached from the insertion handle.The force required to do so would have made removal during surgery extremely difficult.The investigation revealed the locking mechanism in the nail was seated too high into the nail, causing it to bind to the connecting screw.This matter was further investigated and it resulted in a recall of nail lots that had been inadequately inspected for lock prong placement.The dhr for lot: 9954217 shows the lock prong placement for this nail was inspected and found to be adequate.Extensive testing was completed that shows that the locking mechanism remains in the set position during vibration and transit to the hospitals so the lock should have been in the correct place prior to the surgery.At some point prior to inserting the connecting screw, the locking mechanism moved too high within the nail and caused the connecting screw to bind to it.Without further information, the precise cause of the high lock prong placement cannot be determined.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: COMPLETE RADIOLUCENT INSERTION HANDLE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5342057
• MDR Text Key: 34997559
• Report Number: 2520274-2016-10027
• 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,Followup,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.012
• Device Lot Number: 9425779
• Other Device ID Number: (01)10886982070289(10)9425779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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
• Patient Age: 93 YR
• Patient Weight: 79