REDUCTION FORCEPS FOR 1.3 TO 2.0MM SCREWS/SOFT LOCK 03.130.291

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-11 for REDUCTION FORCEPS FOR 1.3 TO 2.0MM SCREWS/SOFT LOCK 03.130.291 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[188845414] Product complaint # (b)(4). 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 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


[188845415] It was reported that on an unknown date, during routine inspection of the reduction forcep for screw it was noticed that the metal band that allows the quick release handle on the reduction forcep appears to have broken away from the set screw. There was no patient involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01224
MDR Report Key9821796
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-11
Date of Report2020-02-12
Date Mfgr Received2020-03-26
Device Manufacturer Date2015-10-01
Date Added to Maude2020-03-11
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
Manufacturer G1SYNTHES TUTTLINGEN
Manufacturer StreetUNTER HASSLEN 5
Manufacturer CityTUTTLINGEN 78532
Manufacturer CountryGM
Manufacturer Postal Code78532
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREDUCTION FORCEPS FOR 1.3 TO 2.0MM SCREWS/SOFT LOCK
Generic NameFORCEPS
Product CodeHTD
Date Received2020-03-11
Returned To Mfg2020-03-13
Model Number03.130.291
Catalog Number03.130.291
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 2020-03-11

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