1.5MM SYSTEM HIGH TORGUE (HT), SD, X-DR, SCR, 5/PK N/A 95-6104

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-10 for 1.5MM SYSTEM HIGH TORGUE (HT), SD, X-DR, SCR, 5/PK N/A 95-6104 manufactured by Biomet Microfixation.

Event Text Entries

[183095632] Zimmer biomet complaint # (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: unknown screw, catalog number ni. Lot number ni. Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[183095633] It was reported that while attempting to insert a screw, the screw fractured halfway into the bone. The fractured portion of the screw was not removed and remained in the bone.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2020-00153
MDR Report Key9813130
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-27
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-10
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. LAKESHIA SMOOT
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9047414400
Manufacturer G1BIOMET MICROFIXATION
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal Code32218
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand Name1.5MM SYSTEM HIGH TORGUE (HT), SD, X-DR, SCR, 5/PK
Generic NameORTHOPEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
Product CodeGWO
Date Received2020-03-10
Model NumberN/A
Catalog Number95-6104
Lot Number390230
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-10

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