MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTERFSCRW W/DISP SHTH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/13/2022
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 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.
Event or Problem Description
On (b)(6) 2022, it was reported by an arthrex employee via email that on (b)(6) 2022, patient had an acl procedure done using an autograft, which was fixed with a tightrope system in the femur and a bio-composite screw in the tibia.On (b)(6) 2022, surgeon performed a revision surgery on patient to remove all implants due to an infection.Additional information received on 4/12/2022: the part and lot number for the autograft used in the original procedure remains unknown.This infection was discovered five day after procedure on (b)(6) 2022 and an ar-1588rt acl tightrope, lot 13822428, and an ar-1390c bio-composite interference screw, lot 10964516, were removed from the patient during the revision surgery on (b)(6) 2022.Surgeon had the infected areas biopsied and the results came back as a (b)(6) culture to (b)(6).The explanted devices have been sent to the lab for further testing.Currently, the patient is being treated with antibiotics.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• 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: 14192882
• Report Number: 1220246-2022-04781
• Device Sequence Number: 14536079
• Product Code: MAI
• UDI-Device Identifier: 00888867015517
• UDI-Public: 00888867015517
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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 Expiration Date: 04/30/2024
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1390C
• Device Lot Number: 10964516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/25/2022
• Date Device Manufactured: 05/13/2020
• 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