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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; SCREW, FIXATION, BONE
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ARTHREX, INC. TENO SCRW,BIO-COMP; SCREW, FIXATION, BONE Back to Search Results
Model Number TENO SCRW,BIO-COMP
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
 
Event or Problem Description
It was reported that during an ankle surgery while inserting the screw it broke into several small fragments.The surgeon needed additional 30 minuets to retrieve all parts out of the patient.No harm for patient, operator or third party was reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 23-jun-2020: it was further reported that an additional anesthesia was needed.
 
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Brand Name
TENO SCRW,BIO-COMP
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10279362
Report Number1220246-2020-01948
Device Sequence Number13625690
Product Code HWC
UDI-Device Identifier00888867018778
UDI-Public00888867018778
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K051726
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/31/2023
Device Model NumberTENO SCRW,BIO-COMP
Device Catalogue NumberAR-1547BC
Device Lot Number10566232
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/23/2020
Initial Report FDA Received Date07/15/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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