MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER HANDLE, RATCHETING; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCREWDRIVER HANDLE, RATCHETING
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery the bearing of the device broke.No broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe (b)(6) 2023: it was confirmed that no broken parts fell into the patient.
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 is confirmed.One unpackaged ar-1999 serial/batch number 8002026 was received for investigation.Functional testing was not performed due to the damage to the device.Upon visual evaluation, it was noted that the instrument ratcheting system was disassembly.Per dhr review certificate of conformance manufacturing year 2020.It is still being determined how many cleaning cycles the device has been exposed to.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: SCREWDRIVER HANDLE, RATCHETING
• 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: 17098378
• Report Number: 1220246-2023-06885
• Device Sequence Number: 11236459
• Product Code: LXH
• UDI-Device Identifier: 00888867025936
• UDI-Public: 00888867025936
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: SCREWDRIVER HANDLE, RATCHETING
• Device Catalogue Number: AR-1999
• Device Lot Number: 8002026
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/21/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown