MAUDE Adverse Event Report: ARTHREX, INC. SWVLK TENO BIO-COMP 7X 19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SWVLK TENO BIO-COMP 7X 19.1MM
Health Effect - Clinical Codes	Muscle Spasm(s) (1966); Pain (1994); Weakness (2145); Foreign Body In Patient (2687)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Device was reported to have been discarded at time of revision procedure.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via fda medwatch letter (mw5080256) that a patient underwent a tenodesis surgery on their right shoulder on (b)(6) 2017.The fiberlink suture was passed through the torn biceps tendon and then fed through the eyelet of an arthrex swivelock anchor and seated into the pilot hole on the proximal humerus.Eleven months post-op, the patient had a sudden pain/spasm in their right shoulder.Imaging tests revealed numerous "loose bodies" in the front and back of the patient's shoulder joint.On (b)(6) 2018, an arthroscopic procedure was performed for removal of the foreign bodies.The broken fragments of the screw were removed via three holes in the patient's shoulder.The biceps tendon was noted to be absent.The screw was unstable and defective.Seven weeks post-op from the second surgery, the patient is still experiencing severe pain and spasms with greatly decreased strength in the right arm.No function to biceps long head deformity and permanent deformity.Additional information provided 11/15/2018: the patient has provided scanned arthroscopic photos.The scans show the ¿foreign bodies¿ floating in her shoulder.This failed device has caused her biceps to slip off the humerus and so it is non-functional.Patient has been having intense spasms ever since early (b)(6).It may be necessary to have another operation if this does not resolve.The surgeon advised that there may be more pieces in the shoulder joint.Patient's arm is weak, painful and looks deformed.

• Brand Name: SWVLK TENO BIO-COMP 7X 19.1MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8107707
• Report Number: 1220246-2018-00767
• Device Sequence Number: 1616509
• Product Code: MAI
• UDI-Device Identifier: 00888867020603
• UDI-Public: 00888867020603
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2018

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 Model Number: SWVLK TENO BIO-COMP 7X 19.1MM
• Device Catalogue Number: AR-1662BCC-7
• Device Lot Number: 10039498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/27/2018
• 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