MAUDE Adverse Event Report: ARTHREX, INC. SHEATH HANDLE ASSEMBLY, SUPRAPATELLAR; INTRAMED FIXATN ROD AND ACCESS

Model Number	SHEATH HANDLE ASSEMBLY, SUPRAPATELLAR
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/21/2025, a sales representative reported via (b)(4) that an 0641-000 sheath handle assembly's supra patellar disposable sheath was attached the gray t portion with the black handle.The sheath was inserted into the knee and the tibia imn was completed.When the sheath was removed at the end of the case the silver button that holds the supra patellar sheath and top together was broken off and located on the floor.An xray was obtained to make sure that no pieces of the device were in the patient and the procedure was completed with no additional time or issues.
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 0641-000 batch 212501 was received for evaluation.Visual inspection revealed that a t-shaped silver piece was detached.It was also noted that the device has a crack in the material where the t-shaped silver piece was originally set.The most likely cause of the reported failure is wear and tear on the device, which was manufactured in 2021.

• Brand Name: SHEATH HANDLE ASSEMBLY, SUPRAPATELLAR
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• 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: 22748443
• Report Number: 1220246-2025-03343
• Device Sequence Number: 12940500
• Product Code: HSB
• UDI-Device Identifier: 00848665027617
• UDI-Public: (01)00848665027617(11)210825(10)212501
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/05/2025

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: SHEATH HANDLE ASSEMBLY, SUPRAPATELLAR
• Device Catalogue Number: 0641-000
• Device Lot Number: 212501
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown