MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-05 for manufactured by Synthes Usa.

Event Text Entries

[4147546] During surgery for a radial shortening, the surgeon was drilling a second 2. 5mm wire through the small distractor on the external fixator and the 2. 5mm wire jammed in the threaded hole. The second wire never made it into the patient? S bone; it jammed into the distractor. The distractor was pulled off the first 2. 5mm wire and away from the patient. The second wire could not be removed. The second wire was cut and the distractor was re-applied over the first wire. Surgeon then completed the surgery by placing a 1. 6mm wire into a different hole. Surgery continued without further incident and necessary compression was achieved. Due to this event an additional 15-30 minutes was added to operating room time. This report is for an unknown part. This report is 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[11398372] Device is an instrument and is not implanted or explanted subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. Without a lot number the device history records review could not be completed. Placeholder.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2013-07608
MDR Report Key3501782
Report Source05,07
Date Received2013-12-05
Date of Report2013-10-29
Date of Event2013-10-29
Date Mfgr Received2013-10-29
Date Added to Maude2014-03-18
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 FDA0
Event Location0
Manufacturer ContactELIZABETH TASCIONE
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeDZK
Date Received2013-12-05
Returned To Mfg2013-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES USA
Manufacturer AddressWEST CHESTER PA


Patients

Patient NumberTreatmentOutcomeDate
10 2013-12-05

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