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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS PLATE, FIXATION, BONE

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ARTHREX, INC. SCREW, CANCELLOUS PLATE, FIXATION, BONE Back to Search Results
Model Number SCREW, CANCELLOUS
Device Problems Material Fragmentation (1261); Difficult to Remove (1528)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/12/2020
Event Type  Injury  
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 Description
It was reported that after an initial hto surgery on (b)(6) 2019, it was found that the proximal screws broke post op and remains in the patients body. The screws could not be removed during the revision surgery. It's unclear if the screws broke in situ or during the revision surgery. No more information are available. No x-rays are available. Devices are already discarded and not available for investigation. Further questions will be asked. Update 12-aug-2020, asa: it was reported by the customer that some proximal screws were broken. When removing the plate and screws they all broke around 1cm from screwhead. The plate and screws were (partially) taken out. The surgeon decided that he did not want to place another plate due to partial consolidation.
 
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Brand NameSCREW, CANCELLOUS
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 Key10422393
MDR Text Key203457115
Report Number1220246-2020-02059
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867010574
UDI-Public00888867010574
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K032187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSCREW, CANCELLOUS
Device Catalogue NumberAR-13280-55
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/18/2020 Patient Sequence Number: 1
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