MAUDE Adverse Event Report: Arthrex, Inc. IMPL SYS, ALLOGRAFT GRAFTLINK CP 2; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a patient, through review of medical records, that on (b)(6)2025, the patient underwent acl reconstruction.The operative report indicates the following arthrex products were used for the procedure: ar-4580r fiberstitch (lot unknown), ar-4580s fiberstitch (lot 25c05) ar-1588al-cp2 allograft graftlink implant system (lot 15317362); ar-4580 fiberstitch (lot 25d03), ar-4020-c-09 fastthread biocomposite interference screw, 9 x 20 mm (lot 15454391) and ar-4020c-09 and ar-4020p-10 fastthread peek interference screw 10 mm × 20 mm (lot 15231522a).Patient medical records support implantation of the ar-4020c-09 and ar-4020p-10 interference screws.Information provided by the patient alleges an ar-4030c-10 biocomposite interference screw, 10 x 30 mm may have been used and fractured during implantation; however, no such event is documented in the november 24, 2025 operative report.The exact intraoperative sequence, device utilization, and circumstances surrounding the alleged fracture of a device could not be conclusively determined from the available records.Following a reported traumatic event at home where the patient's left knee was hyperextended and twisted, the patient underwent revision acl reconstruction on (b)(6)2025.The surgeon documented a partial tear of the previously implanted acl graft and removal of the prior femoral and tibial interference screws.The revision operative note indicates an ar-1588al-cp2 graftlink cp2 (lot 15490181), ar-1593-bc biocomposite swivelock (lot 15426254), and two ar-4020p-10 peek interference screws (lots unknown) were used in the procedure.The operative report indicates use of the two peek interference screws for femoral and tibial fixation.Other medical records suggest the swivelock was used for secondary tibial fixation.No complications were reported.Despite the revision procedure, the patient continued to report pain, instability, and inability to bear weight.At a preoperative evaluation on (b)(6) 2026, the patient reported ongoing symptoms requiring a brace, wheelchair, and walker.Mri review reportedly demonstrated an intact acl graft, and examination documented a stable knee with a negative lachman test and firm endpoint.On (b)(6)2026, at the patient's request and following unsuccessful conservative treatment, the patient underwent left knee arthroscopy with extensive debridement, partial medial meniscectomy, acl graft removal, and hardware removal.Intraoperative findings included an intact but vertically oriented acl graft, degenerative cartilage changes, and a small medial meniscus tear.An interference screw located within the roof of the notch was removed and submitted for pathology.Pathology later described the explanted hardware as an intact threaded plastic implant measuring approximately 2 cm in length with no identifiable inscription.The removed hardware was reported as an intact peek interference screw.Available records do not conclusively identify which previously implanted device was removed, and there is insufficient documentation to determine whether all previously implanted hardware was removed.No operative complications were reported.On (b)(6) 2026, the patient sought another orthopedic surgeon¿s opinion for persistent left knee pain, weakness, foot drop, and inability to bear weight following acl reconstruction, revision acl reconstruction, and subsequent graft and hardware removal.The surgeon noted that the source of the patient's symptoms could not be clearly determined from the records reviewed and recommended rehabilitation and physical therapy rather than additional acl revision surgery at that time.At follow-up on (b)(6) 2026, the patient reported improvement following graft and hardware removal and was ambulatory with crutches and a functional brace.Examination demonstrated healed incisions, full extension, and approximately 125 degrees of flexion.Continued physical therapy was recommended.At follow-up on(b)(6)2026, ct review reportedly demonstrated evidence of prior femoral screw removal, residual bone fragments adjacent to the femoral tunnel, no metallic hardware within the knee, and an intact tibial screw remaining within the tibial tunnel.The patient reported increasing posterior knee pain and difficulty bearing weight.Conservative management was recommended, and no additional orthopedic intervention was advised at that time.No additional information has been provided to date.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50006510
• Report Number: 1220246-2026-04005
• Device Sequence Number: 13357754
• Product Code: MBI
• UDI-Device Identifier: 00888867395350
• UDI-Public: (01)00888867395350(11)240916(17)280630(10)15317362
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
• Device Catalogue Number: AR-1588AL-CP2
• Device Lot Number: 15317362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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 Age: 45 YR
• Patient Sex: Female