MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	AR-7237-7
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Scarring (2061); Limited Mobility Of The Implanted Joint (2671)
Date of Event	10/04/2018
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.
Event or Problem Description
After an initial anterior cruciate ligament surgery (recorded with (b)(4)) patient came for consultation and showed the clinical picture of a movement restriction with painful episodes.Mri showed a significantly enlarged mediopatellar plica.Based on the findings, agreement of arthroscopic surgery with resection of the adhesions.The second surgery took place on (b)(6) 2018.Diagnosis: restricted movement of right knee joint, plica mediopatellaris / suspected cyclops after anterior cruciate ligament plastic.Procedure performed: partial meniscectomy.The surgery was an arthroscopy, with anchor screw, resection of scarring, resection of clear plica mediopatellaris in right knee joint.Evaluation post-op: the examination after end of anaesthesia shows correct mobility to the extent permitted.Part number ar-7237 was involved in surgery.No further information will be provided.
Additional Manufacturer Narrative
This is a follow-up submission to change the device part number from an ar-7237 to an ar-7237-7.
Event or Problem Description
After an initial anterior cruciate ligament surgery (recorded with (b)(4)) patient came for consultation and showed the clinical picture of a movement restriction with painful episodes.Mri showed a significantly enlarged mediopatellar plica.Based on the findings, agreement of arthroscopic surgery with resection of the adhesions.The second surgery took place on (b)(6) 2018.Diagnosis: restricted movement of right knee joint, plica mediopatellaris / suspected cyclops after anterior cruciate ligament plastic.Procedure performed: partial meniscectomy.The surgery was an arthroscopy, with anchor screw, resection of scarring, resection of clear plica mediopatellaris in right knee joint.Evaluation post-op: the examination after end of anaesthesia shows correct mobility to the extent permitted.Part number ar-7237 was involved in surgery.No further information will be provided.Update 08-august-2019: after review of the facility sales it was discovered that the original part number (ar-7237) provided was incorrect.The correct part number, verified by facility sales orders, is ar-7237-7.

• Brand Name: FIBERTAPE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8686247
• Report Number: 1220246-2019-01139
• Device Sequence Number: 3019661
• Product Code: GAT
• UDI-Device Identifier: 00888867041738
• UDI-Public: 00888867041738
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: AR-7237-7
• Device Catalogue Number: AR-7237
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other