MAUDE Adverse Event Report: ARTHREX, INC. CANN DEPTH DEV FOR 6.7 MM CANN SCRWS; DEPTH GAUGE

Model Number	CANN DEPTH DEV FOR 6.7 MM CANN SCRWS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an ankle fusion surgery the k-wire won't pass through the cannulated tip of the device.The surgeon then used another k-wire to measure the length.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 23-jul-2024: it was further reported that the tip of the device ar-8967dg looks damaged.The k-wire used with the device was ar-8967kts.[07:45] (b)(6).Update dw 30-jul-2024: further information was provided that due to the damaged depth gauge the surgeon used another k-wire against the inserted k-wire to calculate the length of screw needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.One unpackaged ar-8967dg serial/batch number (b)(6) was received for evaluation.Functional testing with a pin wire found no obstruction when passed through the cannulation.The evaluation of the instrument noted that the shaft¿s tip was bent; discoloration spots and faded laser marks were also found.The most likely cause of the reported failure, where the k-wire won¿t pass through the cannulated tip, can be attributed to user error as the reported malfunction cannot be replicated.

• Brand Name: CANN DEPTH DEV FOR 6.7 MM CANN SCRWS
• Common Device Name: DEPTH GAUGE
• 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: 19906133
• Report Number: 1220246-2024-07021
• Device Sequence Number: 21015563
• Product Code: HTJ
• UDI-Device Identifier: 00888867056725
• UDI-Public: 00888867056725
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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: CANN DEPTH DEV FOR 6.7 MM CANN SCRWS
• Device Catalogue Number: AR-8967DG
• Device Lot Number: 051842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 01/14/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/28/2024; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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