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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. TORQUE SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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EXACTECH, INC. TORQUE SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 06/01/2023
Event Type  Injury  
Event Description
It was reported that this patient's shoulder was revised.Glenoid failed, broken inferior screw.Patient was revised to a djo glenoid and glenosphere and exactech tray and liner 40mm.Event occurred years after initial surgery.Patient was last known to be in stable condition following the event.Product will not be returned due to hospital policy.
 
Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): glenosphere, tray, liner.
 
Manufacturer Narrative
The revision reported was likely the result of the fracture of a compression screw, which led to the reported glenoid failure.However, this could not be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.
 
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Brand Name
TORQUE SCREW
Type of Device
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66 ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523771140
MDR Report Key17262266
MDR Text Key318575621
Report Number1038671-2023-01536
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10
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