HOLDING SLEEVE 313.97

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for HOLDING SLEEVE 313.97 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[185544604] 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


[185544605] It was reported that on an unknown date, the holding sleeve and cruciform screwdriver would not lock together. The issue was observed during testing. There was no patient involvement. Concomitant devices reported: cruciform screwdriver (part number 313. 96, lot l808139, quantity 1). This report involves one holding sleeve. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01570
MDR Report Key9890552
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-27
Date of Report2020-03-06
Date Mfgr Received2020-03-06
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
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 G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHOLDING SLEEVE
Generic NameSCREWDRIVERS
Product CodeHXX
Date Received2020-03-27
Model Number313.97
Catalog Number313.97
Lot NumberL884643
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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