COUNTERSINK W/CENTERING PINS F/1.5MM, 2.0MM & 2.7MM SCREWS 310.810

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 2018-07-23 for COUNTERSINK W/CENTERING PINS F/1.5MM, 2.0MM & 2.7MM SCREWS 310.810 manufactured by Oberdorf Synthes Produktions Gmbh.

Event Text Entries

[114730397] This patient information is unknown. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (510k): device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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


[114730398] Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during jaw osteosynthesis surgery with unilock system on (b)(6) 2018, during the perforation with 1. 5 x 12mm drill, the center-pin broke and remained in the patient. The surgery was successfully completed without further issue. It is unknown if there was a surgical delay. Patient outcome is unknown. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030965-2018-55213
MDR Report Key7710963
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-07-23
Date of Report2018-07-01
Date of Event2018-07-01
Date Mfgr Received2018-07-01
Date Added to Maude2018-07-23
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 ContactMR. MICHAEL COTE
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1WERK BETTLACH (CH)
Manufacturer StreetMURACHERSTRASSE 3
Manufacturer CityBETTLACH 2544
Manufacturer CountrySZ
Manufacturer Postal Code2544
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOUNTERSINK W/CENTERING PINS F/1.5MM, 2.0MM & 2.7MM SCREWS
Generic NameDRIVER,WIRE,BONE DRILL MANUAL
Product CodeDZJ
Date Received2018-07-23
Catalog Number310.810
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 2018-07-23

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