MAUDE Adverse Event Report: ARTHREX, INC. Arthrex®; SCREW, FIXATION, BONE

Model Number SUTR ANCH,CRKSCRW FT III

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by the patient that approximately 3 years ago he had undergone a rotator cuff repair surgery during which an arthrex screw was implanted.Patient had been doing fine since the surgery with full range of motion and no pain.Approximately 4-6 weeks prior to this report patient began having pain, internal bleeding and formed a large hematoma on his upper arm.It was discovered via x-ray that the screw was no longer in the bone and was loose in his upper arm.The patient reports he did not suffer any injury or trauma that may have caused to implant to migrate and come out of the bone.The surgeon will perform a second surgery to remove the loose screw.The second surgery is scheduled for (b)(6) 2020.The patient has requested that the explanted device be given to him after surgery.At time of initial report the patient did not have the actual part number of the implant but will obtain and provide.Additional information obtained 01/10/2020: patient reports the following: revision surgery took place (b)(6) 2020, by same surgeon, at same facility.The surgeon removed the loose screw with no complications.Patient reports healing is going well, although the shoulder is sore from the surgery itself.Patient had follow up with surgeon 4 days post-op and all was well at that point.Explanted screw was saved and was given to the patient.Patient reports he was unable to locate number on it that might indicate the part number.Patient indicates that he was very pleased with the surgeon and facility staff.Patient expects that if the healing continues as hoped and expected then all will be ok additional information obtained 02/05/2020: sales rep was able to obtain the patient's implant part number from the original surgery facility.: ar-1928sf-3, lot 1240884.This suture anchor, cork screw ftiii was explanted during the (b)(6) 2020 procedure.

• Brand Name: Arthrex®
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9750594
• MDR Text Key: 190519098
• Report Number: 1220246-2020-01695
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867023727
• UDI-Public: 00888867023727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: SUTR ANCH,CRKSCRW FT III
• Device Catalogue Number: AR-1928SF-3
• Device Lot Number: 1240884
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other