MAUDE Adverse Event Report: ARTHREX, INC. BLADE, PARALLEL GRAFT KNIFE, 9MM (5-BOX); SAW BLADE

Model Number	BLADE, PARALLEL GRAFT KNIFE, 9MM (5-BOX)
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/01/2024, it was reported by a facility representative via (b)(4) that an ar-2285-09 graft knife blades will not fit into the handle.There is an unusual amount of force needed to seat blades.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
The complaint cannot be verified without evaluating the device.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is damage to the parallel graft knife, which prevents the attachment of the parallel knife.H.1 set as n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.

• Brand Name: BLADE, PARALLEL GRAFT KNIFE, 9MM (5-BOX)
• Common Device Name: SAW BLADE
• 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: 18923663
• Report Number: 1220246-2024-01535
• Device Sequence Number: 12364847
• Product Code: GFA
• UDI-Device Identifier: 00888867026650
• UDI-Public: 00888867026650
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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 Expiration Date: 12/31/2024
• Device Model Number: BLADE, PARALLEL GRAFT KNIFE, 9MM (5-BOX)
• Device Catalogue Number: AR-2285-09
• Device Lot Number: 10565647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown