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
Complaint is confirmed.One box with five sealed pouches of an ar-2285-09 serial/batch number (b)(6) was received for evaluation.Visual inspection found no issues with the device.Functional testing of two devices with an ar-2285h batch number 01032401 found resistance when the knives were attempted to slide inside the parallel graft knife.The blade fit too tight.The device does not fully sit in the handle.Evaluation of dimension per drawing c11427 at revision 13, found that the radius (r.025) is larger measuring approximately.079.Measurement of the 8° angle was found to be smaller (measured approximately 7°); however, not conclusion can be drawn from these measurements as they are reference measurements per drawing.The measurement of the width found the device meet the drawing specifications.The cause for the reported failure is a supplier manufacturing issue.Corrections: 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: 18923650
• Report Number: 1220246-2024-01534
• Device Sequence Number: 12364737
• 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 Model Number: BLADE, PARALLEL GRAFT KNIFE, 9MM (5-BOX)
• Device Catalogue Number: AR-2285-09
• Device Lot Number: 22D05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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