MAUDE Adverse Event Report: ARTHREX, INC. 1.5MM HEX, CMP FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	1.5MM HEX, CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8737-37 driver shaft had an issue during a first mtp arthrodesis procedure on (b)(6) 2023.After the mtp joint was prepped, the surgeon through in a.86 k wire, and drilled over the wire with a 2.0 cannulated drill.Then they placed a 2.5x40 compression ft screw on power with the device.Once the screw was inserted 3/4 the length, the driver tip broke off inside the head of the screw.The wire was removed, and a dental pick was used to extract the broken tip of the driver from the head of the screw.The broken piece was removed from the patient.The screw was inserted the rest of the way by hand with a new driver.An x-ray was obtained to make sure there were no other pieces left in the patient.The surgery finished successfully as planned, and no harm was done to the patient.A second surgery will not be needed.This was discovered during use with no patient harm.Additional information has been requested.
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.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided photo that displays an ar-8737-37 cannulated driver shaft with a broken tip.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
On (b)(6) 2023, the sales representative provided the following information via email: there was no case delay, and additional anesthesia was not needed.The complaint device had been discarded.

• Brand Name: 1.5MM HEX, CMP FT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 17662507
• Report Number: 1220246-2023-07726
• Device Sequence Number: 20599970
• Product Code: LXH
• UDI-Device Identifier: 00888867127159
• UDI-Public: 00888867127159
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 01/16/2025

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: 1.5MM HEX, CMP FT
• Device Catalogue Number: AR-8737-37
• Device Lot Number: 1391617
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown