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	Insufficient Information (4580)
Date of Event	05/08/2023
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 05/08/2023, it was reported by a sales representative via sems that an ar-8737-37 hexalobe driver broke upon insertion of 2.5mm compression screws.This was discovered during a case, device broke during use.Additional information requested.
Additional Manufacturer Narrative
The complaint is confirmed.Two unpackaged ar-8737-37 serial/batch number (b)(6) was received for investigation.No functional testing for these two devices with the tip broken off.Visual evaluation found that the two returned hex driver tip was broken off.It was noted that the devices shown discoloration and faded laser marks.Most likely cause is attributed to over-torquing/over-engaging the driver with the screw head.

• 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: vik bajnath ; 8009337001
• MDR Report Key: 17032326
• Report Number: 1220246-2023-06817
• Device Sequence Number: 6516116
• Product Code: LXH
• UDI-Device Identifier: 00888867127159
• UDI-Public: 00888867127159
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/30/2024

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: 1.5MM HEX, CMP FT
• Device Catalogue Number: AR-8737-37
• Device Lot Number: 1392235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown