SAWTOOTH ARTHRO. SLOTTED DRILL GUIDE 214562 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-06-23 for SAWTOOTH ARTHRO. SLOTTED DRILL GUIDE 214562 * manufactured by Mitek Products.

Event Text Entries

[61989] The doctor noted metal shavings in the joint after drilling using the mitek arthroscopic drill and drill guide.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1221934-1997-00011
MDR Report Key100858
Report Source05
Date Received1997-06-23
Date of Report1997-06-20
Date of Event1997-05-15
Date Mfgr Received1997-05-15
Device Manufacturer Date1997-01-01
Date Added to Maude1997-06-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSAWTOOTH ARTHRO. SLOTTED DRILL GUIDE
Generic NameDRILL GUIDE
Product CodeHXY
Date Received1997-06-23
Returned To Mfg1997-06-20
Model Number214562
Catalog Number*
Lot Number970179
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key99368
ManufacturerMITEK PRODUCTS
Manufacturer Address60 GLACIER DR. WESTWOOD MA 02090 US
Baseline Brand NameARTHROSCOPIC SLOTTED DRILL GUIDE, S.T.
Baseline Generic NameGUIDE, DRILL
Baseline Model No*
Baseline Catalog No214562
Baseline ID*
Baseline Device FamilyDRILL GUIDE
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY

Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-06-23
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