MAUDE Adverse Event Report: ARTHREX, INC. IMP SYS INTBRACE KNEE LIG AUGMENT REPR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMP SYS INTBRACE KNEE LIG AUGMENT REPR
Health Effect - Clinical Codes	Itching Sensation (1943); Reaction (2414)
Date of Event	05/16/2017
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 remains in the patient and was not returned for evaluation.Therefore, the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported that the patient underwent an mcl repair in her left knee on (b)(6) 2017 where two arthrex double loaded 3.0 biocomposite suturetaks and an mcl internal brace with two 4.75 biocomposite swivelocks and a fibertape were implanted.Hives and itching all over body and accompanying dermatographia began happening the day of surgery upon return home from the procedure.This has been constant since then with relief only provided by allegra.Allergy scratch test, comprehensive blood-work, chest x-rays, and contact dermatitis patch test have all been done and returned inconclusive for cause of reaction.After numerous allergen and contact dermatitis tests, most common allergens have been ruled out and a few clinicians the patient has seen, suspect that the reaction may be due to the parts used in her surgery last year.

• Brand Name: IMP SYS INTBRACE KNEE LIG AUGMENT REPR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7734403
• Report Number: 1220246-2018-00573
• Device Sequence Number: 752243
• Product Code: MAI
• UDI-Device Identifier: 00888867109698
• UDI-Public: 00888867109698
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: No Information
• Device Model Number: IMP SYS INTBRACE KNEE LIG AUGMENT REPR
• Device Catalogue Number: AR-5511-CP
• Device Lot Number: 10077899
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1