UNK - GUIDES/SLEEVES/AIMING: AIMING ARM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for UNK - GUIDES/SLEEVES/AIMING: AIMING ARM manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[185545750] 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.
Patient Sequence No: 1, Text Type: N, H10


[185545751] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01555
MDR Report Key9889267
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-04
Date of Event2020-03-03
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK - GUIDES/SLEEVES/AIMING: AIMING ARM
Generic NameGUIDE
Product CodeFZX
Date Received2020-03-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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