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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Model Number 72202902
Device Problem Material Disintegration (1177)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case (b)(4).
 
Event Description
It was reported that, during an arthroscopic procedure, when fixing the "5.5mm footprint ultra peek suture anchor" to the patient, the product dusted.The procedure was successfully completed without delay using a back-up device.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: breakage of the suture anchor can occur if insertion sites are not properly prepared prior to implantation.Excessive force during insertion can cause failure of the suture anchor or insertion device.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
Manufacturer Narrative
H10: h3, h6: part of the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection found that the device was returned with out any suture.There was debris on the device.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the raw material found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that, during an arthroscopic procedure, when fixing the "5.5mm footprint ultra peek suture anchor" to the patient, the product dusted.The procedure was successfully completed without delay using a back-up device.No further complications were reported.
 
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Brand Name
FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
MDR Report Key11345250
MDR Text Key232458064
Report Number1219602-2021-00343
Device Sequence Number1
Product Code MBI
UDI-Device Identifier03596010650535
UDI-Public03596010650535
Combination Product (y/n)N
PMA/PMN Number
K093897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/04/2021
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 Number72202902
Device Catalogue Number72202902
Device Lot Number2057329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2021
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received02/18/2021
Supplement Dates Manufacturer Received03/22/2021
11/03/2021
Supplement Dates FDA Received03/23/2021
11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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