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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARTIVA, INC CARTIVA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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CARTIVA, INC CARTIVA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number MTK-10
Device Problem Dull, Blunt (2407)
Patient Problem Burn(s) (1757)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly, the surgeon was using the reamer and was unable to ream the bone due to the reamer being dull.This resulted in shards falling off the reamer and burning of the bone.Another second disposable kit was used to complete the surgery.
 
Manufacturer Narrative
H6: the product was returned for review.Visual examination of the returned part confirms / shows - the mtk-10 drill was returned and assessed at cartiva, inc.Visual inspection found no outward signs of damage or misuse.According to manufacturing records, the drill bit was produced per specification.
 
Event Description
Allegedly, the surgeon was using the reamer and was unable to ream the bone due to the reamer being dull.This resulted in shards falling off the reamer and burning of the bone.Another second disposable kit was used to complete the surgery.
 
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Brand Name
CARTIVA
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
CARTIVA, INC
6120 windward parkway
suite 220
alpharetta GA 30005
MDR Report Key10574615
MDR Text Key208187006
Report Number3009351194-2020-00013
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
PMA/PMN Number
K181348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 08/26/2020
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? Yes
Device Operator Health Professional
Device Model NumberMTK-10
Device Lot Number181466
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2020
Initial Date Manufacturer Received 08/26/2020
Initial Date FDA Received09/23/2020
Supplement Dates Manufacturer Received11/05/2020
Supplement Dates FDA Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
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