MAUDE Adverse Event Report: ARTHREX INC. FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSU

Catalog Number	AR-3633
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported, that during a proximal tenodesis procedure the surgeon was using the implant and drilled for it and upon inserting the implant it pulled out.In the attempt to remove the inserter; the anchor came out with the driver and one of the prongs was left behind in the joint.Surgeon did not take x-rays and washed the area out.It is unknown if the piece was retrieved from the patient.X-rays were not taken and the surgeon was not too concerned.Opened another fibertak and completed the procedure.Patient: male in his 30's.Follow-up investigation: the implant itself did not pull out on it's own.The implant pulled out because it was attached to the driver and when the driver was being removed the implant came with it.The prong that remained in the patient was from the inserter device, not the implant itself.The fibertak that was used to complete the procedure was placed in the same drill hole as the anchor that pulled out with the driver.The ar-3633 anchor and the inserter device that comes with the anchor are both being returned to arthrex for evaluation.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The evaluation revealed that one of the tabs broke-off at the inserter's distal tip.Additionally, fracture face show signs of being bent.The device met all material specifications as received.Complainant's event is most likely caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported, that during a proximal tenodesis procedure the surgeon was using the implant and drilled for it and upon inserting the implant it pulled out.In the attempt to remove the inserter; the anchor came out with the driver and one of the prongs was left behind in the joint.Surgeon did not take x-rays and washed the area out.It is unknown if the piece was retrieved from the patient.X-rays were not taken and the surgeon was not too concerned.Opened another fibertak and completed the procedure.Patient: male in his 30's.Follow-up investigation: the implant itself did not pull out on it's own.The implant pulled out because it was attached to the driver and when the driver was being removed the implant came with it.The prong that remained in the patient was from the inserter device, not the implant itself.The fibertak that was used to complete the procedure was placed in the same drill hole as the anchor that pulled out with the driver.The ar-3633 anchor and the inserter device that comes with the anchor are both being returned to arthrex for evaluation.

• Brand Name: FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSU
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7380862
• Report Number: 1220246-2018-00112
• Device Sequence Number: 1233559
• Product Code: MBI
• UDI-Device Identifier: 00888867276925
• UDI-Public: 00888867276925
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: AR-3633
• Device Lot Number: S705120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR