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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SUPRAPATELLAR INSERTION GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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ARTHREX, INC. SUPRAPATELLAR INSERTION GUIDE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number SUPRAPATELLAR INSERTION GUIDE
Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 11/29/2021
Event Type  malfunction  
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.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On (b)(6) 2021, it was reported by a sales representative via sems that an 1239-100 locking knob cross-threaded into an 1255-300 suprapatellar guide.This was discovered during a tibial nail procedure.Surgeon could not complete case due to the devices getting stuck.About an hour or so after the case, sales representative was finally able to remove the knob from the guide but they were both unsalvageable due to the cross-threading.
 
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.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event Description
On (b)(6) 2021, it was reported by a sales representative via sems that an 1239-100 locking knob cross-threaded into an 1255-300 suprapatellar guide.This was discovered during a tibial nail procedure.Surgeon could not complete case due to the devices getting stuck.About an hour or so after the case, sales representative was finally able to remove the knob from the guide but they were both unsalvageable due to the cross-threading.
 
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Brand Name
SUPRAPATELLAR INSERTION GUIDE
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key13054589
MDR Text Key286061528
Report Number1220246-2021-04148
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00848665039153
UDI-Public00848665039153
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSUPRAPATELLAR INSERTION GUIDE
Device Catalogue Number1255-300
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/21/2021
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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