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 2012-05-03 for PINS/WIRES manufactured by Synthes Usa.

Event Text Entries

[17411381] A pt was tested on an unk date for an acromion fracture with tension wires and screws. Subsequently, the pt returned to the surgeon complaining of pain. Examination and x-rays revealed a non-union of the acromion. The pt was returned to the operating room for removal of all hardware, which was reportedly intact. The pt was revised to two (2) 2. 7mm locking compression plates and screws. This report is #3 of 3 for the same event.
Patient Sequence No: 1, Text Type: D, B5


[17751534] Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2012-00737
MDR Report Key2572762
Report Source05,07
Date Received2012-05-03
Date of Report2012-04-09
Date Mfgr Received2012-04-09
Date Added to Maude2012-05-15
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 ContactJODI TEMPLE
Manufacturer Street1302 WRIGHTS LANE E.
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePINS/WIRES
Generic NamePINS/WIRES
Product CodeDZK
Date Received2012-05-03
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSYNTHES USA
Manufacturer AddressWEST CHESTER PA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-05-03

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