MAUDE Adverse Event Report: ARTHREX, INC. SUPRAPATELLAR INSERTION GUIDE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUPRAPATELLAR INSERTION GUIDE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/10/2025, it was reported by a sales representative via (b)(4) that an 1255-300 insertion guide, the bolt that attaches to the gig the bolt and jig cross threaded together and got stuck, broke the screwdriver because it was tight.Noticed during a case and swapped with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged 1255-300 batch 212469 was received for evaluation.Visual inspection noted signs of wear and tear as the laser marks are fading.It was noted that the device arrived for investigation with the 1239-100 batch 212007.The most likely cause of the reported failure is wear and tear on the device, which was manufactured in 2021.

• Brand Name: SUPRAPATELLAR INSERTION GUIDE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 23464541
• Report Number: 1220246-2025-04980
• Device Sequence Number: 10269368
• Product Code: HSB
• UDI-Device Identifier: 00848665039153
• UDI-Public: (01)00848665039153(11)210825(10)212469
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070444
• 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,Followup
• Report Date (Section B): 01/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUPRAPATELLAR INSERTION GUIDE
• Device Catalogue Number: 1255-300
• Device Lot Number: 212469
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown