PINS/WIRES

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 2012-12-13 for PINS/WIRES manufactured by Synthes Usa.

Event Text Entries

[3180975] Surgeon inserted screw in the medial malleolus using a 1. 6 mm trocar and placed 2 guide wires in patient. Surgeon measured and used a 3. 2 drill bit; when the drill bit was removed, the 1. 6 guide wire came out in the drill bit. The surgeon had to drill another hole and the tech attempted to remove the guide wire out of the drill bit so that it could be re used. She tried both a needle driver and pliers unsuccessfully. She used the trocar to try to push it out and stuck herself with it in the pinkie finger. She broke scrub and followed facility protocol for her injury. The physician used another drill bit in the set to complete the procedure. This is 3 of 3 reports for this event.
Patient Sequence No: 1, Text Type: D, B5


[10286908] Device used for treatment and not diagnosis. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2012-03937
MDR Report Key2872423
Report Source05,07
Date Received2012-12-13
Date of Report2012-11-15
Date of Event2012-11-15
Date Mfgr Received2012-11-15
Date Added to Maude2012-12-13
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 FDA0
Event Location0
Manufacturer ContactSHERRY LAING
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePINS/WIRES
Product CodeDZK
Date Received2012-12-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES USA
Manufacturer AddressWEST CHESTER PA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-12-13

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