1.5/2.3 MM MULTISCREW CADDY LID 80-1820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-27 for 1.5/2.3 MM MULTISCREW CADDY LID 80-1820 manufactured by Acumed Llc.

Event Text Entries

[187742159] The lid (80-1820) and caddy (80-2391) interface was physically examined and is stuck as described in the description. The lid could not be removed by hand during this evaluation. The metal on metal contact between the sliding lid and the caddy base can cause wear over time due to the friction during the sliding on and off motion. The anodization of the components does help this motion, however it appears that the anodization has worn where the two components interface, which can be a factor in the lid getting stuck. Additional mdrs associated with this event: 3025141-2020-000035: caddy.
Patient Sequence No: 1, Text Type: N, H10


[187742160] During surgical treatment of a routine finger fracture in an elderly patient, the surgeon requested a screw but the lid could not be removed from the caddy. This prevented the surgeon from finishing as he planned and surgery was delayed at least 15 minutes, trying to open the screw caddy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3025141-2020-00034
MDR Report Key9763629
Report SourceDISTRIBUTOR
Date Received2020-02-27
Date of Report2020-02-07
Date of Event2020-02-07
Date Mfgr Received2020-02-07
Date Added to Maude2020-02-27
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 ContactMS. MICKI ANDERSON
Manufacturer Street5885 NE CORNELIUS PASS ROAD
Manufacturer CityHILLSBORO OR 97124
Manufacturer CountryUS
Manufacturer Postal97124
Manufacturer G1ACUMED LLC
Manufacturer Street5885 NE CORNELIUS PASS ROAD
Manufacturer CityHILLSBORO OR 97124
Manufacturer CountryUS
Manufacturer Postal Code97124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1.5/2.3 MM MULTISCREW CADDY LID
Generic NameTRAY, SURGICAL, INSTRUMENT: LID
Product CodeFSM
Date Received2020-02-27
Returned To Mfg2020-02-17
Model Number80-1820
Catalog Number80-1820
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerACUMED LLC
Manufacturer Address5885 NE CORNELIUS PASS ROAD HILLSBORO OR 97124 US 97124


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-27

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