MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 105MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.305

Device Problem Failure to Align (2522)

Patient Problem Sedation (2368)

Event Date 03/05/2016

Event Type  Injury  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 105mm non sterile product was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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 trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2016, a misalignment occurred.The patient presented with a proximal third shaft fracture as a result of a motorcycle accident.The patient was said to have hard bone and the canal was narrow.The surgeon selected a tfna due to the features.The fracture was reduced with a serrated reduction clamp, the bone was reamed as appropriate and the surgeon advanced the nail into the bone.While advancing, the guide wire position was superior in the femoral head and neck and the surgeon wanted it inferior.The surgeon pulled the guide wire back, and advanced the nail distally.The nail seemed to be ¿maxed out¿ as the flare on insertion handle hit the top of the greater trocar and would not allow the nail to advance any further.The nail did advance slightly.The surgeon inserted the first guide wire for the helical blade and under imaging realized the wire was bent and removed it.A second identical guide wire was inserted and it appeared that the wire was taking the original path before they made the adjustments with the nail.The lateral cortex drill bit was used to drill for the helical blade and collided with the nail; nail fragments remained embedded in the patient.The surgeon tried to advance the drill bit and it would not advance any further due to hard bone and/or fighting the guide wire per to radiographic images.The surgeon attempted to insert the helical blade and it would not advance all the way; therefore, the surgeon removed the helical blade.The sizes of all devices being used were verified and everything matched appropriately; it was suspected there was a misalignment.The surgeon attempted to insert another wire and at the same time the canulet, the internal sleeve for the wire fell on the floor.The surgeon requested a trochanteric fixation nail (tfn) instead and the entire tfna construct was removed completely; some fragments remained in the femoral neck from the drill bit striking the nail.A tfn was inserted and the case was completed successfully.There was no additional harm to patient nor was any additional medical intervention to remove the fragments reported.There was a surgical delay of 90 minutes due to the malfunctions, trouble-shooting intra-operatively, attempts to reinsert instrumentation and having to abandon initial work to use a different system.Post-operatively after sterile processing, the equipment was inspected and it was noticed that the drill bit and helical blade assembly (helical blade and inserter) would not advance through the threaded sleeve.The tfna construct was reassembled and it was confirmed that there was a misalignment.This is report 4 of 8 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

A product development evaluation was completed: a tfna helical blade (04.038.305) was received with numerous scratches in the anodization on the shaft of the blade.One flute at the tip of the blade is also scratched and dented.The helical blade was returned after the surgeon was unable to fully insert it into the femur.This was because the helical blade inserter failed to insert all the way through the guide sleeve.During the surgery, the guide sleeve became slightly bent, prohibiting passage of the blade inserter.Because the guide sleeve was also misaligned with respect to the nail, the blade collided with the right edge of the proximal locking hole, leaving an indentation that matches the width of the tip of the flutes.Contact with the nail caused some material on the outer shaft of the blade to scratch away.The bend in the guide sleeve prevented the blade inserter from fully inserting the helical blade.The misalignment of the guide sleeve caused the tip of the blade to collide with the anterior edge of the proximal locking hole, damaging the blade and the nail.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

During evaluation of the complaint by the manufacturer additional information was received.The nail had a tight fit within the bone, making it difficult to adjust its position after insertion.After the guide wire for the head element did not follow the desired trajectory, the surgeon tried to rotate the nail using the insertion handle while keeping the guide sleeve lowered down to the bone.The opposing forces from the bone pressing on the edge of the guide sleeve and the aiming arm rotating with the nail caused the guide sleeve to bend near the taper.The bent guide sleeve was now misaligned with respect to the nail, causing the lateral drill bit to collide with the nail.The bent sleeve also prevented the helical blade inserter from passing through, which made it impossible to fully insert the helical blade.

• Brand Name: TFNA HELICAL BLADE 105MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5518816
• MDR Text Key: 40928087
• Report Number: 3003506883-2016-10051
• 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: 03/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.305
• Device Lot Number: 7976772
• Other Device ID Number: (01)10886982099044(10)7976772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR