MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; SCREW, FIXATION, BONE

Model Number	TENO SCRW,BIO-COMP
Health Effect - Clinical Codes	Inflammation (1932); Irritation (1941); Pain (1994); Synovitis (2094); Weakness (2145)
Date of Event	06/18/2018
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 therefore the complainant's event could not be verified.Device disposition was unknown by patient.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported by the patient that she underwent a right ankle lateral ligament allograft reconstruction and proximal tendon procedure on (b)(6) 2017 during which the following arthrex devices were implanted: biotenodesis screw, ar-1547bc, lot 10044519; 6.25 x 15 mm screw, ar-1562bc, lot 10040350; and 5.5 x 15mm screw, ar-1555bc, lot 10050790.Also implanted was another manufacturer's allograft tissue, tendon semitendinosus product.After surgery and since healing the patient experienced the following issues: pain where the new tendon was supposed to be, a lump that stuck out of the skin, inflammation, weakness, pain.Patient was treated with physical therapy, bracing, limited driving and limited physical activity.On (b)(6) 2017 patient underwent a right peroneal tendosynovitis and prominent hardware removal procedure, by the same surgeon at the same facility, due to failing conservative treatment for patient's persistent posterolateral ankle pain and a palpable mass.Surgeon dislocated the peroneal tendons from the retrofibular groove and they were free of any new tears.There was extensive tenosynovitis with thickened tenosynovium, which was sharply debrided.There was a prominent bio-tenodesis screw from the previous reconstruction.Since the ligament's anatomy about the fibula had headed the surgeon removed the screw as it was abutting the peroneal and clearly an irritant.It is unknown which of the original implant screws were the one that was explanted.There is no mention in the revision op report of anything else being explanted.

• Brand Name: TENO SCRW,BIO-COMP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7684824
• Report Number: 1220246-2018-00533
• Device Sequence Number: 1452739
• Product Code: HWC
• UDI-Device Identifier: 00888867018778
• UDI-Public: 00888867018778
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 04/30/2018
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1547BC
• Device Lot Number: 10044519
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/13/2018
• 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: 29 YR