11.0MM TI HELICAL BLADE 115MM-STERILE
Report
- Report Number
- 3003506883-2017-10181
- Event Type
- Malfunction
- Date Received
- August 22, 2017
- Date of Event
- August 1, 2017
- Report Date
- August 1, 2017
- Manufacturer
- SYNTHES ELMIRA
- Product Code
- HSB
- PMA / PMN Number
- K011857
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (11.0MM TI HELICAL BLADE 115MM-STERILE, PART NUMBER 456.308S, LOT NUMBER 9800830). THE CONCOMITANT PARTS WERE RETURNED AS CONCOMITANT DEVICES WITHOUT ALLEGED COMPLAINT CONDITIONS. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THE PARTS CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THEM. THE RETURNED PARTS ARE INCLUDED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. UPON INSPECTION IT WAS NOTICED THAT TWO OF THE RETURNED HELICAL BLADES (456.307, H073709 AND 456.308, 9800830) EXHIBITED SIGNIFICANT DAMAGE TO THEIR SHAFT REGIONS, INCLUDING SCRATCHES AND GOUGES. A THIRD HELICAL BLADE (456.307, H063338) EXHIBITED MINOR SCRATCHES BUT NO DAMAGE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ONE OF THE TWO RETURNED NAILS (456.499, 6952460) EXHIBITED DAMAGE IN THE HOLE INTENDED TO RECEIVE HELICAL BLADES. IT APPEARED AS THOUGH SOME MATERIAL HAD BEEN DEPOSITED IN THE INNER DIAMETER (ID) OF THE HOLE. THE OTHER RETURNED NAIL (456.499, 7588666) EXHIBITED MINOR SIGNS OF USE, BUT NO DAMAGE WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DUE TO THE DAMAGE NOTICED ON TWO OF THE RETURNED HELICAL BLADES AND ONE OF THE DAMAGED NAILS, IT WAS NOTICED THAT THEY WERE NOT ABLE TO FUNCTION AS INTENDED. IT WAS ATTEMPTED TO RECREATE THE COMPLAINT CONDITION AND THE TWO DAMAGED BLADES WERE NOT ABLE TO PASS THROUGH THE APPROPRIATE MATING HOLE IN EITHER NAIL, AND THE DAMAGED NAIL WAS NOT ABLE TO RECEIVE ANY OF THE RETURNED BLADES, WHICH CONFIRMED THE COMPLAINT CONDITION. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION, DRAWING REVIEW, AND ROOT CAUSE ANALYSIS WERE PERFORMED. ALL THREE RETURNED HELICAL BLADES WERE MANUFACTURED AFTER 20JUN06 SO DRAWING 456_301 WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. BOTH RETURNED NAILS WERE MANUFACTURED AFTER 22JUL05 SO DRAWINGS 456_451 AND 456_451_1 WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. POSSIBLE ROOT CAUSES FOR INITIAL MISALIGNMENT COULD HAVE BEEN LOOSE NAIL/INSERTION HANDLE CONSTRUCT(S) AND/OR AIMING DEVICES, SOFT TISSUE DEFLECTION, SURGICAL CHALLENGES DUE TO UNIQUE PATIENT ANATOMY, AND NOT FOLLOWING THE ASSOCIATED SURGICAL TECHNIQUE GUIDE AS INTENDED. IT IS EMPHASIZED ON PAGE 20 OF THE ASSOCIATED TECHNIQUE GUIDE, TO CONFIRM THAT THE NAIL IS TIGHTLY CONNECTED TO THE INSERTION HANDLE, ESPECIALLY AFTER HAMMERING. IT WAS STATED IN THE COMPLAINT DESCRIPTION THAT AFTER EXPERIENCING RESISTANCE THE SURGEON TAPPED THE INSERTER INSTRUMENT. IF THE SURGEON INITIALLY EXPERIENCED DIFFICULTIES LINING UP THE AIMING INSTRUMENTATION PROPERLY DUE TO THE POTENTIAL COMPLICATIONS LISTED ABOVE, ATTEMPTING TO FORCE THE BLADE(S) INTO PLACE COULD HAVE CAUSED THE DAMAGE SUSTAINED BY TWO OF THE BLADES AND ONE OF THE NAILS. THE COMPLAINT CONDITION COULD HAVE OCCURRED DUE TO LOOSE AIMING DEVICES, WHICH COULD CONTRIBUTE TO MISALIGNMENT, AND THEN ATTEMPTING TO FORCE A MISALIGNED BLADE INTO PLACE COULD HAVE CAUSED THE DAMAGE NOTICED ON THE RETURNED PARTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(6). PATIENT AGE/DATE OF BIRTH, GENDER AND WEIGHT ARE UNKNOWN. ADDITIONAL PRODUCT CODE: HWC (B)(4). DUE TO INTRA-OPERATIVE ISSUES, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. PART 456.308S, LOT 9800830: RELEASE TO WAREHOUSE DATE: MAY 23, 2015. EXPIRATION DATE: APRIL 30, 2024. MANUFACTURING SITE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11.0MM TI HELICAL BLADE 115MM STERILE PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE 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 WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.
IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A LEFT SUB-TROCHANTERIC FEMUR FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) (TFNA) TROCHANTERIC FIXATION NAIL ADVANCED, ONE (1) TFNA HELICAL BLADE AND ONE (1) DISTAL LOCKING SCREW. DURING THE PROCEDURE, AFTER THE SURGEON HAD ALREADY IMPLANTED A (TFN) TROCHANTERIC FIXATION NAIL AND AS HE WAS ATTEMPTING THE INSERT A TFN 11MM/ 115MM HELICAL BLADE THRU THE ALREADY IMPLANTED TFN NAIL, IT WAS NOTED THAT AFTER HE HAD ATTACHED THE HELICAL BLADE IMPLANT WITH THE INSERTER INSTRUMENT THRU THE NAIL, THE HELICAL BLADE WOULD ONLY INSERT ABOUT HALF WAY THRU THE NAIL. SURGEON THEN TAPPED THE INSERTER INSTRUMENT WITH THE BLADE ATTACHED WITH THE MALLET INSTRUMENT FOR PROPER BLADE POSITIONING OF THE IMPLANT. UNDER X-RAY THE PATIENT¿S SUB- TROCHANTERIC BONE FRACTURE BECAME DISPLACED. SURGEON THEN REMOVED THE HALF INSERTED HELICAL BLADE IMPLANT. THE PATIENT¿S FRACTURE WAS REDUCED AGAIN. SURGEON CHOSE ANOTHER SMALLER SIZED TFN 11.0MM/ 110MM HELICAL BLADE TO IMPLANT AND WAS USING THE SAME ALREADY INSERTED NAIL. AGAIN, THIS HELICAL BLADE IMPLANT WOULD ONLY ADVANCE HALF WAY THRU THE NAIL AND ALSO DISPLACED THE FRACTURE. AT THIS POINT IN THE PROCEDURE THE SURGEON CHOOSES TO REMOVE THE TFN NAIL WAS ALONG WITH THE 11.0MM/ 110MM HELICAL BLADE. SUBSEQUENTLY, AT THE BACK TABLE, THE TECHNICIAN CHOOSES ANOTHER (TFN) TROCHANTERIC FIXATION NAIL WITH ANOTHER 11.0MM/ 110MM HELICAL BLADE IMPLANT THAT WAS AVAILABLE IN ANOTHER TFN SET FOR TESTING. IT WAS FOUND THESE IMPLANTS ALSO WOULD NOT ALIGN CORRECTLY. AGAIN, EVEN WITH THESE NEW TFN NAIL AND HELICAL BLADE IMPLANTS, IT WAS REPORTED THAT THE HELICAL BLADE IMPLANT WOULD ONLY ADVANCE HALF WAY THRU THE NAIL. SURGEON CHOSE TO USE THE TFNA IMPLANT AND INSTRUMENT SET THAT WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY USING THE TFNA IMPLANTS, AND THE PATIENT IS REPORTED IN STABLE CONDITION. DUE TO THESE ISSUES, THERE WAS REPORTED TWO (2) HOUR OPERATING ROOM TIME DELAY. CONCOMITANT DEVICES: BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS (PART 357.369, LOTS 4875203 & 4545110, QUANTITY 2); BUTTRESS COMPRESSION NUT (PART 357.371, LOTS T102704 & 6897199, QUANTITY 2); 11.0MM/3.2MM WIRE GUIDE 222MM (PART 357.381, LOTS 4878490 & 3452756, QUANTITY 2); 3.2MM TROCAR 232MM (PART 357.383, LOTS 4543103 & 5598242, QUANTITY 2); INSERTION HANDLE TROCHANTERIC FIXATION NAILS (PART 357.411, LOTS 3328R6 AND 6366784, QUANTITY 2); MALLET (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590564 | 11.0MM TI HELICAL BLADE 115MM-STERILE | ROD, FIXATION, INTRAMEDULLARY | HSB | SYNTHES ELMIRA | 9800830 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |