HANDLE FOR 90? SCREWDRIVER 03.505.004

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 2019-05-30 for HANDLE FOR 90? SCREWDRIVER 03.505.004 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[146638475] Additional device product codes: dzj, hxx. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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


[146638476] It was reported that on an unknown date, threads on 90 degree drill handpiece are stripped, the shaft for 90-degree driver would not thread on. It did thread onto a different handpiece though. There was no patient involvement. Concomitant device reported: unknown screwdriver shaft (part #: unknown, lot #: unknown, quantity #: 1). This report is for one (1) handle for 90 degree screwdriver.. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2019-58388
MDR Report Key8655073
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-30
Date of Report2019-05-01
Date Mfgr Received2019-06-04
Device Manufacturer Date2014-05-15
Date Added to Maude2019-05-30
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 SELZACH
Manufacturer StreetBOHACKERWEG 5
Manufacturer CitySELZACH 2545
Manufacturer CountrySZ
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHANDLE FOR 90? SCREWDRIVER
Generic NameDRILL, BONE, POWERED
Product CodeDZI
Date Received2019-05-30
Returned To Mfg2019-06-04
Model Number03.505.004
Catalog Number03.505.004
Lot Number8140696
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2019-05-30

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