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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAYENNE MEDICAL SURELOCK 1.4MM FLEX ANCHOR; FASTENER, FIXATION
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CAYENNE MEDICAL SURELOCK 1.4MM FLEX ANCHOR; FASTENER, FIXATION Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Report source: foreign: japan.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the during surgery, the anchor came out from the patients burr hole while attached to the tip of the device although the surgeon implanted it following the normal usage.It is also noted that the tip of the inserter was fractured along with the anchor.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon evaluation of returned device, it was determined to be not reportable as the returned anchor was not fractured.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.
 
Event Description
Upon evaluation of returned device, it was determined to be not reportable as the returned anchor was not fractured.No serious injury or harm to the patient reported for this event or prior events with same or similar products.The initial report should be voided.
 
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Brand Name
SURELOCK 1.4MM FLEX ANCHOR
Type of Device
FASTENER, FIXATION
Manufacturer (Section D)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer (Section G)
CAYENNE MEDICAL
16597 n 92nd street
scottsdale AZ 85260
Manufacturer Contact
jennifer rapsavage
56 e. bell dr
warsaw, IN 46582
5745260384
MDR Report Key16022720
MDR Text Key308370250
Report Number3006108336-2022-00042
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132867
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/23/2024
Device Model NumberN/A
Device Catalogue NumberCM-9614F
Device Lot Number78588-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
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