MAUDE Adverse Event Report: ARTHREX, INC. DISPS KIT,TRANS-TIB ACL W/ SAWBLD; SAW BLADE

Model Number	DISPS KIT,TRANS-TIB ACL W/ SAWBLD
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
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.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 8/18/2023, it was reported by a sales representative via sems that an ar-1897s transtibial acl disposables kit had 2 of 5 guide pins that did not come with the beath pin in them.This was discovered upon opening the package during a procedure, with no reported adverse event or patient harm.Additional information requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: DISPS KIT,TRANS-TIB ACL W/ SAWBLD
• 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: emily shafer ; 8009337001
• MDR Report Key: 17746312
• Report Number: 1220246-2023-07903
• Device Sequence Number: 11808201
• Product Code: GFA
• UDI-Device Identifier: 00888867022454
• UDI-Public: 00888867022454
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/13/2025

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: DISPS KIT,TRANS-TIB ACL W/ SAWBLD
• Device Catalogue Number: AR-1897S
• Device Lot Number: 15070669
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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