MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 105MM-STERILE; ROD, FIXATION, BONE

Catalog Number 456.306S

Device Problem Failure to Advance (2524)

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

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

Additional device product code: hwc.(b)(6).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.A device history record (dhr) review was performed on part # 456.306s, lot # h097232: release to warehouse date: 01 june 2016, expiration date: 30 april 2025, manufacturing site: (b)(6): a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0 ti helical blade 105mm sterile product was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.However before sterilization, the work order was split to include a thermal rinse process.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.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 a helical blade would not go through a nail during a trochanteric fixation nail (tfn) procedure on (b)(6) 2017.As the surgeon attempted to insert the helical blade, the blade went one-quarter of the way through the nail and would not advance any farther.A lag screw was also tried and that also would not go through the nail.While attempting to back the helical blade out of the nail, the threads of a blade guide sleeve and a buttress compression nut were damaged.It was confirmed that the nail packaging and etching stated "130 degrees".The same was confirmed for the aiming arm.The construct was taken out and alignment was confirmed.Subsequently, the original nail was replaced with a different nail, and the construct was successfully implanted without issue.There was a reported surgical delay of 15 minutes to remove the original nail.No additional x-rays or additional medical intervention were required.The procedure was successfully completed with the patient in stable condition.Concomitant devices reported: 130 deg aiming arm f/ trochanteric fixation nails (part number 357.366, lot number unknown, quantity 1).This report is for one (1) 11.0mm ti helical blade 105mm-sterile.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

A product development investigation was performed.The following four (4) devices were received at cq for investigation.Trochanteric fixation nail (part 456.315s, lot 9848997), helical blade (part 456.306s, lot h097232), blade guide sleeve (part 357.369 / lot 4611680), buttress compression nut (part 357.371 / lot 4546697).A device history record (dhr) review, device inspection, functional test, and drawing review were performed as part of this investigation.One (1) 11.0mm titanium trochanteric fixation nail screw, 105mm, sterile (reported part 04.032.105s / lot unknown) was reported but was not returned for further investigation.No new malfunctions were observed during the course of this investigation.The returned instruments and implants are components of the titanium trochanteric fixation nail (tfn) system intended for the intramedullary fixation of proximal femur fractures.The devices are specifically for the insertion of the head element into the nail.The implants (nail and helical blade) were received intact with surface wear.During functional testing the helical blade slid freely through the intended oblique hole of the nail.The locking mechanism of the nail was in the retracted position upon receipt at customer quality (cq).When the locking mechanism was removed it was observed that the prong was bent outward and showed scraping along the inside surface.The helical blade and nail showed corresponding areas of wear consistent with rubbing against the locking mechanism of the nail.Thus, the condition is consistent with attempted insertion of the blade with the locking mechanism inadvertently advanced such that it was blocking a portion of the oblique hole.In conclusion, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the devices are already damaged.Based on the date of manufacture the relevant drawings were reviewed.A definitive root cause could not be determined.The bent locking mechanism is consistent with attempted insertion of the blade with the locking mechanism inadvertently advanced such that it was blocking a portion of the oblique hole.Technique guides note that the locking mechanism is to be engaged after insertion of the head element.It also note ¿to verify the appropriate position of the locking mechanism for the screw, pass the 5.0mm flexible hexagonal screwdriver though the cannulated connecting screw and turn counterclockwise until it stops." the damaged threads are consistent with the reported use of impact to back out the blade.The blade guide sleeve threads are not intended to be impacted.Per relevant technique guide the blade is intended to be removed with the helical blade extractor (357.378), the slide hammer (357.25), and hammer (357.22) and the screw is intended to be removed with the helical blade coupling screw (357.377) and screw inserter/extractor (357.428).During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for their intended use when employed and maintained as recommended.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: 11.0MM TI HELICAL BLADE 105MM-STERILE
• Type of Device: ROD, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6558681
• MDR Text Key: 74907336
• Report Number: 3003506883-2017-10075
• 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,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.306S
• Device Lot Number: H097232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1