WIRE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-05 for WIRE manufactured by Synthes.

Event Text Entries

[2919384] Pt underwent surgery on (b)(6) 2012 for? Hardware removal from left patella of two? 4. 0 cannulated screws? Screw heads and wires after receiving surgery of? Open reduction and internal fixation of the left patella? On (b)(6) 2011. The pt reported pain and wished to have hardware removed. During the surgery, the hardware and screw heads were identified and removed w/o difficulty according to the operating report. The wires were cut and pulled also w/o difficulty. Two fluoroscopic images confirmed that the hardware were removed successfully and the pt was discharged w/o complications.
Patient Sequence No: 1, Text Type: D, B5


[10238466] (b)(4). Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Mfg records could not be reviewed w/o a lot number.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2012-02167
MDR Report Key2794181
Report Source05,06
Date Received2012-10-05
Date of Report2012-09-06
Date Facility Aware2012-08-15
Report Date2012-09-03
Date Reported to Mfgr2012-09-03
Date Mfgr Received2012-09-06
Date Added to Maude2012-10-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJODI TEMPLE
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

Brand NameWIRE
Generic NameWIRE
Product CodeDZK
Date Received2012-10-05
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES
Manufacturer AddressWEST CHESTER PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-10-05

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