WIRE, FIXATION, INTRAOSSEOUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-27 for WIRE, FIXATION, INTRAOSSEOUS manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[128740437] If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This report is for an unknown guide/compression/k-wires /unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Investigation summary without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10


[128740438] It was reported that on (b)(6) 2018, during an unknown procedure, the part of k-wire broke off in k-wire hole. The k-wire still inside the insertion guide block. Patient was not affected. There was no surgical delay. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2018-55116
MDR Report Key8107496
Date Received2018-11-27
Date of Report2018-11-08
Date of Event2018-11-08
Date Mfgr Received2018-11-27
Date Added to Maude2018-11-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameWIRE, FIXATION, INTRAOSSEOUS
Product CodeDZK
Date Received2018-11-27
Returned To Mfg2018-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-27

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