SMART PIN * 121540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-22 for SMART PIN * 121540 manufactured by Conmed Linvatec Biomaterials Ltd.

Event Text Entries

[20157605] A report of smart pin which split during insertion. The pin was removed. The procedure (left 2nd hammertoe procedure) was finished with other smart pins. Procedure: 2nd left hammertoe. He reports he was using a 5/64 k-wire (1. 984mm) to drill for the 1. 5mm pins. He reports he has been using bioabsorbable pins for 17 years and our product for 3 years without any prior problems. He also reports he does not use the applicator to impact the pin. He reports he cuts off the excess of the pin and then uses a hemostat to push/insert the pin in as he is overdrilling the hole with the k-wire. He reports he has been doing this for 3 years also.
Patient Sequence No: 1, Text Type: D, B5


[20550908] The device has not yet been properly investigated/evaluated. A follow-up report will be created after evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9613278-2007-00008
MDR Report Key839399
Date Received2007-02-22
Date of Report2007-01-10
Date of Event2007-01-10
Date Mfgr Received2007-01-10
Device Manufacturer Date2006-05-01
Date Added to Maude2007-04-21
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 Location0
Manufacturer ContactJOHANNA EINTOLA
Manufacturer StreetHERMIANKATU 6-8 L
Manufacturer CityTAMPERE FI-33720
Manufacturer CountryFI
Manufacturer PostalFI-33720
Manufacturer Phone505291574
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMART PIN
Generic NameBIOABSORBABLE BONE FIXATION DEVICE
Product CodeMBJ
Date Received2007-02-22
Returned To Mfg2007-01-25
Model Number*
Catalog Number121540
Lot NumberS0002575
ID Number*
Device Expiration Date2011-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key826692
ManufacturerCONMED LINVATEC BIOMATERIALS LTD
Manufacturer Address* TAMPERE FI


Patients

Patient NumberTreatmentOutcomeDate
10 2007-02-22

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