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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LARGO Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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CONMED LARGO Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Model Number Y13D
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/06/2022
Event Type  Injury  
Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The distributor reported on behalf of their customer that the y1301, y-knot flex 1.3mm all-suture anchor, (qty 2) was being used during a bankart procedure on (b)(6) 2022 when it was reported, ¿after made a hole by using drill bit and inserted y1301 into bone, a surgeon successfully insert anchor but when he tried to pull out, driver tip was broken.Totally 2 y1301 were failed to operate.One of the two broken fragments appeared to have been embedded into the bone, and the other seemed to be floating in the joint.They couldn't remove it.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed with a 10-minute delay using an alternate device.Further assessment questioning found that the loose component was not removed because it was too small and just disappeared.This report is being raised on the basis of injury due to component of one driver embedded in bone and component of other driver lost in joint.
 
Manufacturer Narrative
Examination of the returned used device, item y1301 confirm the reported problem and found broken off one of the anchor forks.Broken tip is approximately 0.070 long and was not returned for evaluation.The anchor shaft was found slightly bent.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0001.Per the instructions for use, the user is advised when removing driver from pilot hole, pull driver straight out.Do not rotate or oscillate driver about its axis or breakage of driver tip and/or anchor may result.When removing driver from pilot hole, pull driver straight out.Do not rotate or oscillate driver about its axis or breakage of driver tip and/or anchor may result.And the user is also advised to exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The distributor reported on behalf of their customer that the y1301, y-knot flex 1.3mm all-suture anchor, (qty 2) was being used during a bankart procedure on 6oct22 when it was reported, ¿after made a hole by using drill bit and inserted y1301 into bone, a surgeon successfully insert anchor but when he tried to pull out, driver tip was broken.Totally 2 y1301 were failed to operate.One of the two broken fragments appeared to have been embedded into the bone, and the other seemed to be floating in the joint.They couldn't remove it.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed with a 10-minute delay using an alternate device.Further assessment questioning found that the loose component was not removed because it was too small and just disappeared.This report is being raised on the basis of injury due to component of one driver embedded in bone and component of other driver lost in joint.
 
Event Description
The distributor reported on behalf of their customer that the y1301, y-knot flex 1.3mm all-suture anchor, (qty 2) was being used during a bankart procedure on 6oct22 when it was reported, ¿after made a hole by using drill bit and inserted y1301 into bone, a surgeon successfully insert anchor but when he tried to pull out, driver tip was broken.Totally 2 y1301 were failed to operate.One of the two broken fragments appeared to have been embedded into the bone, and the other seemed to be floating in the joint.They couldn't remove it.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed with a 10-minute delay using an alternate device.Further assessment questioning found that the loose component was not removed because it was too small and just disappeared.This report is being raised on the basis of injury due to component of one driver embedded in bone and component of other driver lost in joint.
 
Manufacturer Narrative
H4 - device mfg date; updated due to wrong lot number referenced in error.Manufacturer narrative: examination of the returned used device, item y1301 confirm the reported problem and found broken off one of the anchor forks.Broken tip is approximately 0.070 long and was not returned for evaluation.The anchor shaft was found slightly bent.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame 34,785 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0001.Per the instructions for use, the user is advised when removing driver from pilot hole, pull driver straight out.Do not rotate or oscillate driver about its axis or breakage of driver tip and/or anchor may result.When removing driver from pilot hole, pull driver straight out.Do not rotate or oscillate driver about its axis or breakage of driver tip and/or anchor may result.And the user is also advised to exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.This issue will continue to be monitored through the complaint system to assure patient safety.
 
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Brand Name
Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Manufacturer (Section D)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer (Section G)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer Contact
john berga
11311 concept blvd
largo, FL 33773
7273995358
MDR Report Key15730489
MDR Text Key303039126
Report Number1017294-2022-00104
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K111779
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberY13D
Device Catalogue NumberY1301
Device Lot Number1218603
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received12/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/07/2022
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
Patient EthnicityNon Hispanic
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