MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PEEK CORKSCREW FT; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, PEEK CORKSCREW FT
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Reaction (2414)
Date of Event	07/17/2017
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.The parts remain in patient.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported by a patient through the arthrex website that the patient had undergone tendon repair gluten medius surgery using arthrex anchors in (b)(6) 2017 (specific (b)(6) 2017 date not provided in the initial report).The patient indicated that the surgeon had used suture anchor (4.5 mm 2 ft) and corkscrew fiber wire (14 mm).(specific arthrex product numbers were not provided in the initial report).The patient states the surgeon believes that the patient is having an allergic reaction to the suture material anchored in the bones.Patient is requesting material composition information to be used for possible testing for hypersensitivity/allergies.Patient also states that pain and inflammation have continued.Additional information obtained 9/16/19: patient has provided the operative report which contained the implant information.The patient had received three implants of the same part and lot number during the 2017 procedure.The parts were ar-1927psf-45, corkscrew suture anchors, lot 10113577.Patient states she has been in post operative pain that never went away.Patient participated in over one year of physical therapy so the mobility is there but still limited and painful.Patient has localized stiffness and painful swelling of the hip area even without exercise.The pain and stiffness limited greatly her mobility and prevented her from doing more than 20 minutes of aerobic exercise (easy walking, swimming, climbing stairs).Prolonged sitting greater than 1 hours increases these symptoms.Patient has tried physiotherapy, physical exercise, strengthening exercise, nsaid (in oral form, patches and cream (nsaid and use of muscle relaxants) as well as pressure point therapy (acupuncture).No cultures have been taken to date by any physician.

• Brand Name: SUTURE ANCHOR, PEEK CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9178714
• Report Number: 1220246-2019-01343
• Device Sequence Number: 418955
• Product Code: HWC
• UDI-Device Identifier: 00888867023666
• UDI-Public: 00888867023666
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: 01/31/2022
• Device Model Number: SUTURE ANCHOR, PEEK CORKSCREW FT
• Device Catalogue Number: AR-1927PSF-45
• Device Lot Number: 10113577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other