UNK - GUIDE/COMPRESSION/K-WIRES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for UNK - GUIDE/COMPRESSION/K-WIRES manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[182967423] This report is for an unknown k-wire/ unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[182967424] Device report from the (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, a long trochanteric fixation nail advanced (rfna) was inserted with a lag blade in the femoral head and distal locking was completed. On viewing the final x-rays, it was discovered the lag blade had missed the nail. This was subsequently removed, the jig and handle were reconnected, and a new blade was inserted. Concomitant devices: locking screw (part: 04. 005. 528s, lot: unknown, quantity: 1), locking screw (part: 04. 005. 530s, lot: unknown, quantity: 1), tfna nail (part: 04. 037. 228s, lot: 14l5269, quantity: 1), tfna helical blade (part: 04. 038. 390s, lot: 10l0160, quantity: 1), guide (part: unknown, lot: unknown, quantity: 1), insertion handle (part: unknown, lot: unknown, quantity: unknown). This report is for an unknown k-wire. This is report 4 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2020-01774
MDR Report Key9812688
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-10
Date of Report2020-02-19
Date of Event2020-02-18
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-10
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 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 Report3

Device Details

Brand NameUNK - GUIDE/COMPRESSION/K-WIRES
Generic NameGUIDE
Product CodeFZX
Date Received2020-03-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-10

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