UNKNOWN SCREWDRIVERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for UNKNOWN SCREWDRIVERS manufactured by Medos International Sàrl Ch.

Event Text Entries

[184296986] 510k: this report is for an unk - screwdriver/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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


[184296987] Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the tpal inserter was unable to be dismantled after use. The tip of 3x parts expedium si polyaxial screwdriver distal was shredded. There was no reported surgical delay. There was no patient consequence. This complaint involves one (1) device. This is 1 of 1 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2020-00737
MDR Report Key9860071
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-20
Date of Report2020-02-20
Date of Event2020-02-21
Date Mfgr Received2020-02-20
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal02400
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN SCREWDRIVERS
Generic NameSCREWDRIVERS
Product CodeHXX
Date Received2020-03-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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