MAUDE Adverse Event Report: SYNTHES USA 11.0MM TI HELICAL BLADE 95MM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.304

Device Problem Device Damaged by Another Device (2915)

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

Event Date 12/24/2016

Event Type  malfunction  

Manufacturer Narrative

Patient height reported as 5 feet 4 inches.Additional product code: hwc.(b)(4).Due to intra-operative issues, the device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 an initial trochanteric fixation nail (tfn) procedure for the left femur took place on (b)(6) 2016 where several device malfunctions occurred.The helical blade coupling screw broke into two pieces while being hammered by an unknown mallet.Those pieces were retrieved with difficulty and unspecified additional intervention resulting in a thirty (30) minute surgical delay.Additionally, as the helical blade inserter was removed it was noted the tip was broken in pieces as a result from the hammering.All pieces were retrieved from the broken inserter.It was also determined the threads of the blade guide sleeve became damaged while the surgeon was trying to remove the helical blade inserter.The buttress compression nut for the blade guide sleeve could no longer be turned, and was no longer usable because of the damage to the threads.This pushed the blade guide sleeve into the 130 degree aiming arm.The buttress compression nut and the blade guide sleeve became stuck together.During the implantation of the helical blade and the nail the surgeon reported difficulty in implanting the two devices.A pair of non-synthes pliers was used to remove the helical blade.The surface of the helical blade was scratched while it was being removed.The helical blade was connected to both the helical blade inserter and the inserter coupling screw; these became stuck together for a short time but were later separated.The helical blade and the nail were both removed and replaced with two new back-up implants of the same kind to complete the procedure.Additional devices were also damaged during the procedure: tfn aiming arm and connecting screw were bent by the mallet.The surgeon had concerns the connecting screw might be bent and could not be tightened correctly.The 130 degree aiming arm, guide wire, and 4mm trocar were most likely bent or damaged as well.The procedure was completed successfully.Concomitant devices reported were: non-synthes pliers (part/lot unknown, quantity 1); mallet, (part/lot unknown, quantity 1); tfn nail (part 456.357s, lot unknown, quantity 1).This is report 10 of 10 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 95MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 6255839
• MDR Text Key: 65078709
• Report Number: 2520274-2017-10175
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• 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: 12/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2016
• 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
• Treatment: 1 PART 456.357S, LOT UNKNOWN, TFN NAIL; 1 UNKNOWN MALLET; 1 UNKNOWN PAIR NON-SYNTHES PLIERS
• Patient Age: 83 YR
• Patient Weight: 49