MAUDE Adverse Event Report: ARTHREX MANUFACTURING INC. SWIVELOCK ANCHOR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Lot Number 10886414

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Failure of Implant (1924); Pain (1994); Paralysis (1997); Numbness (2415)

Event Date 08/29/2021

Event Type  Injury  

Event Description

I had a swivelock anchor manufactured by arthrex placed in my shoulder on (b)(6) 2020.On (b)(6) 2021, i bent over to get a phone charging cord off the floor & heard a pop in shoulder and a pain shot down my arm & i lost feeling in my fingers.Couldn't move my arm or feel my fingers for 5 weeks.I found out after mri was done two weeks after incident that the anchor shattered in my shoulder.Anchor parts were removed 5 weeks later.Anchor was in 4 pieces broken.But my pain has continued for over a year now in my upper shoulder and still can't feel 2 of my fingers.After seeing a hand doctor for numbness in fingers that persisted it was determined the anchor broke and caused a bracial plexus injury and has now developed into neurogenic thoracic outlet syndrome.So i got sent to thoracic surgeon & he confirmed this diagnosis.I am back in pt again and facing another surgery.No one seems to care that this happened to me.The doctor nor the arthrex has told me why this anchor broke.I don't want this to happen to anyone else.It hasn't been a little thing and 1 year later i am still suffering in pain every day.I really hope this anchor gets recalled like others have.This anchor didn't break because i did something or was in an accident.I was told that arthrex would tell me why this happened and its over a year and nothing.Fda safety report id #(b)(4).

• Brand Name: SWIVELOCK ANCHOR
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX MANUFACTURING INC.
• MDR Report Key: 15428091
• MDR Text Key: 300208784
• Report Number: MW5112050
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/30/2022
• Device Lot Number: 10886414
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White