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 Code	Unspecified Infection (1930)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via email that a patient underwent an lcl reconstruction procedure using an ar-5511-cp internal brace knee ligament augmentation repair implant system.Post-operative, patient developed an infection.
Additional 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.If the device becomes available for evaluation, a follow-up report will be submitted.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16050820
• Report Number: 1220246-2022-05955
• Device Sequence Number: 17743443
• Product Code: MAI
• UDI-Device Identifier: 00888867109698
• UDI-Public: 00888867109698
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/27/2022

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: Health Professional
• Device Model Number: IMP SYS INTBRACE KNEE LIG AUGMENT REPR
• Device Catalogue Number: AR-5511-CP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 12/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown