INSERTER FOR TI ELASTIC NAILS

Report

Report Number: 3006126083-2015-10031
Event Type: Malfunction
Date Received: April 28, 2015
Date of Event: April 13, 2015
Report Date: April 13, 2015
Manufacturer: SYNTHES RARON
Product Code: LXH
PMA / PMN Number: PEXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: PATIENT EXACT WEIGHT IS REPORTED AS (B)(4). PRODUCT INVESTIGATION SUMMARY: ONE INSERTER, FOR TITANIUM ELASTIC NAILS (PART 359.219 / LOT 1811056) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DOES NOT/WILL NOT FUNCTION: STICKS/JAMS/STUCK.¿ ONE 2.5MM TI ELASTIC NAIL, 440MM (PART 475.925, LOT NUMBER) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: INTRAOPERATIVELY.¿ IT WAS REPORTED THAT WHILE THE PATIENT WAS UNDERGOING AN ELASTIC NAILING SURGICAL PROCEDURE OF HER LEFT PROXIMAL HUMERUS, THE BACK OF THE TITANIUM ELASTIC NAIL (TEN) HANDLE BROKE OFF. AFTER THE TITANIUM NAIL WAS SEATED, A BOLT CUTTER WAS USED TO SEPARATE THE HANDLE FROM REST OF THE NAIL. THE COMPLAINT CONDITION IS CONFIRMED AS THE T-HANDLE OF THE INSERTER WAS BROKEN OFF AND THE ELASTIC NAIL IS STUCK IN THE INSERTER. THE BROKEN CONDITION, WHICH LIKELY RESULTED IN THE JAMMED CONDITION, IS A RESULT OF INADEQUATE STRENGTH OF THE T-HANDLE, WHICH IS BEING ADDRESSED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE INSERTER. IT WAS FOUND THAT THE DEVICE WAS MANUFACTURED IN JANUARY, 2008. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. 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. FURTHER EVALUATION SHOWS THAT THIS INSERTER IS USED WITH A HAMMER GUIDE AND LOCKING SLIDE HAMMER FOR INSERTION OF TITANIUM ELASTIC NAILS (TEN) AND STAINLESS STEEL ELASTIC NAILS (STEN). THE ELASTIC NAILS ARE INTENDED FOR FIXATION OF DIAPHYSEAL FRACTURES WHERE THE CANAL IS NARROW OR FLEXIBILITY OF THE IMPLANT IS PARAMOUNT (ELASTIC NAIL SYSTEM TECHNIQUE GUIDE). THE PIECE OF THE ELASTIC NAIL WAS RECEIVED STUCK IN THE CANNULATION OF THE INSERTER SUCH THAT THE PROXIMAL TIP OF THE NAIL WAS IN THE INSERTER AND A PORTION OF THE NAIL WAS EXTENDING OUT OF THE CHUCK OF THE INSERTER. THE MAJORITY OF THE ELASTIC NAIL WAS NOT RECEIVED AS IT WAS REPORTED TO HAVE BEEN SUCCESSFULLY IMPLANTED. THE INSERTER IS BROKEN SUCH THAT THE DISTAL T-HANDLE IS DETACHED FROM THE REMAINDER OF THE DEVICE. THERE ARE DENTS AND FLATTENING OF THE DISTAL END WHERE IMPACT FROM THE HAMMER WOULD OCCUR. THERE ARE ALSO SCRAPES AND DENTS TO THE DISTAL TIP AND BLUE HANDLE WHERE IMPACT WOULD NOT BE EXPECTED. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT THE CONDITION THAT RESULTED IN COMPLAINT CANNOT BE REPLICATED BECAUSE THE NAIL COULD NOT BE REMOVED FROM THE INSERTER AND THE DEVICES ARE ALREADY SEVERELY DAMAGED. A REVIEW OF THE CURRENT DESIGN DRAWINGS AND THE DRAWING HISTORY FOR THE INSERTER WAS PERFORMED. NO DRAWING ISSUES WERE NOTED AND THE CURRENT DESIGNS WERE FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. BASED ON THE RETURNED CONDITION, IT IS MOST PROBABLE THAT EXCESSIVE HAMMERING OVER THE 7 YEAR LIFESPAN OF THE DEVICE RESULTED IN THE BROKEN T-HANDLE WHICH RESULTED IN THE FUNCTIONAL ISSUES OF THE DISTAL CHUCK. THEREFORE, THE COMPLAINT CONDITION WAS DETERMINED TO BE THE RESULT OF A DESIGN DEFICIENCY WHICH IS BEING ADDRESSED. 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.

Additional Manufacturer Narrative · 1

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.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: MFR DATE: REPORTED AS 6/23/08, SHOULD BE 1/23/08. 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.

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: DATE RETURNED TO MANUFACTURER 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. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE THE PATIENT WAS UNDERGOING AN ELASTIC NAILING SURGICAL PROCEDURE OF HER LEFT PROXIMAL HUMERUS, THE BACK OF THE TITANIUM ELASTIC NAIL (TEN) HANDLE BROKE OFF. NO ADDITIONAL INSTRUMENT WAS AVAILABLE AND THE DAMAGED INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. AFTER THE TITANIUM NAIL WAS SEATED, A BOLT CUTTER WAS USED TO SEPARATE THE HANDLE FROM REST OF THE NAIL. CURRENTLY A PIECE OF TITANIUM NAIL IS IN THE TEN HANDLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS 1 OF 2 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
278239	INSERTER FOR TI ELASTIC NAILS	MISC ORTHO SURGICAL INSTR	LXH	SYNTHES RARON		1811056

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 YR