MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK TENODESIS BIO-COMPOSITE 8 X 19.5 MM; SCREW, FIXATION, BONE

Catalog Number	AR-1662BC-8
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, 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.The contribution of the device to the event as reported could not be determined as the device was requested but has not been returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device requested but not yet received.
Event or Problem Description
It was reported that during a biceps tenodesis, the anchor pulled out when the surgeon was tying the fiberwires over the anchor.An 8.5 mm reamer (ar-1455) had been used prior to insertion.Due to tendon damage caused by the anchor coming out, the procedure was switched to a tenotomy.Additional information obtained 3/14/2017- the tendon was frayed and torn due to the anchor coming out.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, 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.This is a follow-up submission due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the screw's central threads are stripped, and the distal thread is flattened.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel or improper bone preparation prior to insertion.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a biceps tenodesis, the anchor pulled out when the surgeon was tying the fiberwires over the anchor.An 8.5 mm reamer (ar-1455) had been used prior to insertion.Due to tendon damage caused by the anchor coming out, the procedure was switched to a tenotomy.Additional information obtained 3/14/2017- the tendon was frayed and torn due to the anchor coming out.

• Brand Name: SWIVELOCK TENODESIS BIO-COMPOSITE 8 X 19.5 MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6431369
• Report Number: 1220246-2017-00079
• Device Sequence Number: 13587721
• Product Code: HWC
• UDI-Device Identifier: 10888867020587
• UDI-Public: 10888867020587
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2017

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: 10/01/2018
• Device Catalogue Number: AR-1662BC-8
• Device Lot Number: 10074412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/13/2017
• 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