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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. FRAGMENT SCREW, 2.5MMX22MM, HEXALOBE PLATE, FIXATION, BONE

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ARTHREX, INC. FRAGMENT SCREW, 2.5MMX22MM, HEXALOBE PLATE, FIXATION, BONE Back to Search Results
Model Number FRAGMENT SCREW, 2.5MMX22MM, HEXALOBE
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 05/23/2022
Event Type  Injury  
Event Description
On (b)(6) 2022, it was reported by a sales representative via email that an ar-2652cr clavicle fracture plate was implanted in patient on (b)(6) 2022 during a clavicle fracture. Patient felt the plate break and on (b)(6) 2022, it was confirm via x-rays that the plate had broken. A revision surgery has been schedule by the same surgeon that performed the original procedure and it will take place at the same facility. This revision surgery has been scheduled for (b)(6) 2022 to remove all the implanted screws along with the broken plate. Additional information received on 5/26/2022: during original procedure, surgeon implanted the following: one ar-2652cr clavicle fracture plate, one ar-2665-16h fragment screw, one ar-2665-18h fragment screw, one ar-2665-20h fragment screw, one ar-2665-22h fragment screw, one ar-8835-16 low profile screw, one ar-8835-18 low profile screw, two ar-8835-20 low profile screws, one ar-8835l-16 low profile locking screw, and three ar-8835l-18 low profile locking screw. All these implants were removed during revision surgery on (b)(6) 2022. Case was completed successfully using synthes without further issues.
 
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.
 
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Brand NameFRAGMENT SCREW, 2.5MMX22MM, HEXALOBE
Type of DevicePLATE, FIXATION, BONE
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 Key14675065
MDR Text Key294386218
Report Number1220246-2022-05067
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867027749
UDI-Public00888867027749
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123241
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 06/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRAGMENT SCREW, 2.5MMX22MM, HEXALOBE
Device Catalogue NumberAR-2665-22H
Device Lot Number135142
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/24/2013
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2022 Patient Sequence Number: 1
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