SPEED COMPRESSION IMPLANT KIT 11X10X10MM SE-1110

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 2020-03-20 for SPEED COMPRESSION IMPLANT KIT 11X10X10MM SE-1110 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[186758406] The event date is unknown in 2020. 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 as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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


[186758407] It was reported that on an unknown date, neither of the two (2) speed compression plate, one (1) speed compression implant sizing guide, one (1) speed drill kit after they were deployed from the inserter the legs stayed straight and did not compress at all. There was no surgical delay. The procedure was successfully completed. There was no patient consequence. Concomitant device reported: unknown insertion (part # unknown, lot # unknown, quantity # 1). This complaint involves two (2) devices. This is 1 of 2 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01418
MDR Report Key9861412
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-02-22
Date of Event2020-01-01
Date Mfgr Received2020-02-22
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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
Manufacturer G1SYNTHES BME : SAN ANTONIO
Manufacturer Street14785 OMICRON DRIVE #205
Manufacturer CitySAN ANTONIO TX 78245
Manufacturer CountryUS
Manufacturer Postal Code78245
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPEED COMPRESSION IMPLANT KIT 11X10X10MM
Generic NameBONE STAPLE
Product CodeJDR
Date Received2020-03-20
Model NumberSE-1110
Catalog NumberSE-1110
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 2020-03-20

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