FDA.reportPublic FDA data

MAUDE MDR 9889267

MDR report key
9889267
Report number
2939274-2020-01555
Event key
0
Event type
3
Date of event
2020-03-03
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNK - GUIDES/SLEEVES/AIMING: AIMING ARMGUIDEWRIGHTS LANE SYNTHES USA PRODUCTS LLCFZXR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

N

Patient 1

THIS REPORT IS FOR AN UNKNOWN GUIDES/SLEEVES/AIMING: AIMING ARM /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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.

D

Patient 1

IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ORTHOPEDIC PROCEDURE, THE SURGEON EXPERIENCED COMPLICATIONS WHILE USING THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) DEVICES. DIFFICULTIES WERE ENCOUNTERED WHILE USING THE STEPPED DRILL BIT IN PREPARATION FOR THE HELICAL BLADE. AFTER DRILLING, THE SURGEON PROCEEDED TO INSERT THE HELICAL BLADE COMPONENT, WHICH WAS DIFFICULT TO INSERT. THE SURGEON PROCEEDED TO INSERT THE DISTAL LOCKING SCREW AND HAD COMPLICATIONS WITH INSERTING IT. AFTERWARDS THE SURGEON NOTICED THAT AN INCORRECT AIMING ARM (125 DEGREE) WAS UTILIZED. THE TFNA NAIL THAT WAS IMPLANTED WAS A 130 DEGREE NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: TFNA NAIL (PART 04.037.142S, LOT UNKNOWN, QUANTITY 1), CANNULATED STEPPED DRILL BIT (PART 03.037.022, LOT UNKNOWN, QUANTITY 1), THREE-FLUTED DRILL BIT (PART 03.010.061, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM F/IM NAIL-STER (PART 04.005.532S, LOT UNKNOWN, QUANTITY 1), TFNA FENESTRATED HELICAL BLADE 100MM - STERILE(PART # 04.038.400S, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE UNK - GUIDES/SLEEVES/AIMING: AIMING ARM. THIS IS REPORT 3 OF 3 FOR (B)(4).