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

Model Number	LOCKING KNOB, 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 1239-100 locking knob, 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 1239-100 batch, dated 212007, 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, cross-threaded to the 1255-300 batch 212469.The most likely cause of the reported failure is wear and tear on the device, which was manufactured in 2021.

• Brand Name: LOCKING KNOB, 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: 23464742
• Report Number: 1220246-2025-04981
• Device Sequence Number: 10122307
• Product Code: LXH
• UDI-Device Identifier: 00848665006056
• UDI-Public: (01)00848665006056(11)210818(10)212007
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: LOCKING KNOB, INSERTION GUIDE
• Device Catalogue Number: 1239-100
• Device Lot Number: 212007
• 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: 08/18/2021
• 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