11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS 03.025.040

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 2020-03-31 for 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS 03.025.040 manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[186735295] The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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


[186735296] Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent a surgery. During the surgery, the drill bit interfered with the nail. The surgeon drilled a pilot hole with a k-wire, and he could drill and insert a screw. The surgeon didn't know concrete malfunction of the devices. It was not reported how the surgery was completed. The surgical delay was unknown. Concomitant devices reported: connect-scr-cann f/pfn+pfna (part# 357. 029, lot# 2223477, quantity#. This complaint involves seven (7) devices. This is report 3 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2020-02432
MDR Report Key9904362
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-02-28
Date Mfgr Received2020-03-04
Device Manufacturer Date2017-09-28
Date Added to Maude2020-03-31
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 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK H
Manufacturer StreetIM BIFANG 6
Manufacturer CityHAEGENDORF 4614
Manufacturer CountrySZ
Manufacturer Postal Code4614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS
Generic NameMISC ORTHO SURGICAL INSTR
Product CodeLXH
Date Received2020-03-31
Returned To Mfg2020-03-24
Catalog Number03.025.040
Lot NumberL561859
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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