KNIFE LIGHT 10/PK 3300-001-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-06-03 for KNIFE LIGHT 10/PK 3300-001-000 manufactured by Stryker Osteosynthesis-freiburg.

Event Text Entries

[3529228] It was reported that during carpal tunnel procedure while using the knifelight, (b)(4) a piece broke off.
Patient Sequence No: 1, Text Type: D, B5


[10792421] Investigation in progress but not yet complete.
Patient Sequence No: 1, Text Type: N, H10


[15013446] It was reported that during carpal tunnel procedure while using the knifelight, ref # (b)(4) a piece broke off.
Patient Sequence No: 1, Text Type: D, B5


[15332977] The reported event could not be confirmed because there were deformation and cracks in the transparent surrounding instead of breakage. The visual investigation showed that the deformation and cracks of the transparent surrounding was caused by too strong forces in terms of a bending overload during use of the device. Furthermore, it was possible to turn on the light. Based on the performed investigation, no indications were found for any systematic, design or manufacturing related issue.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0008010177-2013-00107
MDR Report Key3141037
Report Source07
Date Received2013-06-03
Date of Report2013-05-09
Date of Event2013-05-02
Date Mfgr Received2013-05-09
Date Added to Maude2013-08-20
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 FDA0
Event Location0
Manufacturer ContactMR. MANISH PATEL
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer PostalD-79111
Manufacturer Phone76145120
Manufacturer G1STRYKER OSTEOSYNTHESIS-FREIBURG
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer Postal CodeD-79111
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKNIFE LIGHT 10/PK
Generic NameSURGICAL INSTRUMENT
Product CodeFSQ
Date Received2013-06-03
Returned To Mfg2013-05-27
Catalog Number3300-001-000
Lot Number12138FE2
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER OSTEOSYNTHESIS-FREIBURG
Manufacturer AddressBOETZINGERSTR. 41 FREIBURG D-79111 D-79111


Patients

Patient NumberTreatmentOutcomeDate
10 2013-06-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.