MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP CRKSCRW FT VENT 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number BIO-COMP CRKSCRW FT VENT 5.5X14.7MM

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Nausea (1970); Rash (2033); Twitching (2172); Dizziness (2194); Anxiety (2328); Sweating (2444); Alteration In Body Temperature (2682)

Event Date 06/06/2013

Event Type  Injury  

Manufacturer Narrative

At this time, it cannot be determined how the device may have caused or contributed to the patient¿s experience.An evaluation of the device cannot be performed as the device remains in the patient and was not returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It was reported by a patient that she had a hamstring repair procedure on (b)(6) 2013.During the procedure an arthrex ar-1927bcnf, bio-comp corkscrew ft vented anchor, lot 538947 was implanted.Patient has had various symptoms which have developed over the years since her surgery.During the past year the symptoms have become severe.Symptoms include the following: severe debilitating reactions to foods (in particular, the latest to this list is sulfa foods; patient cannot tolerate lotions-soaps-any strong smells (which now includes perfumes); immediate migraine headaches around cigarette smoke; patient has a rash on her back that no one in medical world has been able to explain (rash began occurring soon after the surgery and has now lasted for years); additional rashes presenting as well which are staying more permanently now (the latest being around her mouth).Patient states the migraine headaches are unbearable.Patient stated she has blown unusual amounts of blood out of her nose on many occasions.Patient continually has lung and breathing issues.Her body temps as well as blood pressure are always low.Extremities (hands and feet) remain cold the majority of the time.With the migraines patient states she has inability to reason or comprehend or think straight.Latest symptoms now include dizziness and her muscle tissues feel like they've dried up to the point of no elasticity whatsoever.Patient reports deep set bone and muscle fatigue and her hamstring area (where it was attached) are hurting.The pain in her hamstring attachment area seems to be steadier.Patient states she is unable to tolerate working out at all anymore.She has stinging and electrical type pains that also travel down her leg.She is unable to tolerate working out at all anymore.She has also developed more nauseousness now which has not been the case in the past.Patient states the only thing that has come up in test results are that she has a high white blood cell count (which patient states is indicative of her body fighting something) of which no one can seem to pinpoint and tests also reveal a low blood urea nitrogen levels as well as consistent inflammation now which does not clear up in her ears and mostly her right nostril (which is where she seems to blow the most blood on occasion).Patient states she has been unable to work for over two years now.The only thing that has occurred during her slow demise was the hamstring surgery and prior to the surgery patient states she was in perfect optimum health, in the gym every day and was a clean, nontoxic food, and so forth.Patient states she has always taken great care to be her very best.Patient states she has been to emergency rooms numerous times with her symptoms/issues as well as heart issues these last years of which nothing has been able to be found in regular blood work to pinpoint the problem.Additional symptoms the patient reports are: metallic taste in mouth, muscle tics/twitches, night sweats, sensitive teeth/coated tongue, mood swings/anxiety-irritable, small black spots have shown up in her mouth for a time and then go away, feeling of electrical shocks throughout her body and she can no longer tolerate supplements (this problem seems to be growing as well).Patient has requested the material composition of her arthrex implant to work with her doctor to determine if she might possibly have developed an allergy to the device materials which might be causing her symptoms.Material composition has been provided to patient.

• Brand Name: BIO-COMP CRKSCRW FT VENT 5.5X14.7MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 7625941
• MDR Text Key: 112028064
• Report Number: 1220246-2018-00521
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867023406
• UDI-Public: 00888867023406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BIO-COMP CRKSCRW FT VENT 5.5X14.7MM
• Device Catalogue Number: AR-1927BCNF
• Device Lot Number: 538947
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/26/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other