MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT; SCREW, FIXATION, BONE

Model Number SUTR ANCH,CRKSCRW FT

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Fall (1848); Pain (1994); Concussion (2192); Injury (2348); Reaction (2414)

Event Date 12/11/2019

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 that the patient underwent an abductor tendon repair on (b)(6) 2016 where two corkscrew suture anchors, ar-1928snf, were implanted into her left hip.About four months post-op, the patient started to notice pain in her hip.And her skin was tender to the touch over the surgical site.She has seen her surgeon multiple times post-op and has tried physical therapy and pain management to try and get the pain under control.She has also tried otc medications such as, tylenol and aspirin, hip braces, topical pain sprays, creams and ointments; all with no relief.She was then prescribed tramadol 50mg three times a day which he has been on for about a year.Since the start of her pain, the symptoms have now increased to instability and muscle atrophy.She has reached out to the surgeon and has an appointment on friday, (b)(6) 2019.She describes her pain as white hot with weight bearing and also at rest.She has also been referred to specialists and they have ruled out all other causes of the pain.Patient further reported the problem has continually gotten worse over time and due to the instability she has suffered multiple falls with some resulting in injuries such as a concussion, broken arm, broken finger and more.In addition, patient states she has had numerous near misses where she was able to catch herself prior to falling.Patient states she has allergy testing since the surgery and has tested positive for a nickel allergy.Patient was provided with the material composition of the anchor and sutures.The anchor is titanium alloy.Patient has not had any common reaction type symptoms such as rash, hives, oozing, redness, etc.

• Brand Name: SUTR ANCH,CRKSCRW FT
• 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: 9519491
• MDR Text Key: 173445594
• Report Number: 1220246-2019-01534
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00888867023772
• UDI-Public: 00888867023772
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SUTR ANCH,CRKSCRW FT
• Device Catalogue Number: AR-1928SNF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other