MAUDE Adverse Event Report: ARTHREX, INC. DRV SFT,T8 HEXALOBE CANN,STR; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRV SFT,T8 HEXALOBE CANN,STR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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
It was reported that during a screw removal surgery the device broke inside the patient.All fragments were retireved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 07-may-2024: it was confirmed that the distal part of the screw driver broke off.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the drive geometry at the distal tip of the returned driver shaft, t8 hexalobe, cannulated, straight, had broken.The broken piece was returned for investigation.It was not indicated if a torque-indicating adapter had been used with the device.The most likely cause can be attributed to use error due to over-torquing/over-engaging the driver within the screw head.Functional testing was not performed due to the damage to the distal tip of the device.

• Brand Name: DRV SFT,T8 HEXALOBE CANN,STR
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19270893
• Report Number: 1220246-2024-02970
• Device Sequence Number: 17919037
• Product Code: LXH
• UDI-Device Identifier: 00888867046207
• UDI-Public: 00888867046207
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 08/27/2024

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: DRV SFT,T8 HEXALOBE CANN,STR
• Device Catalogue Number: AR-8737-25
• Device Lot Number: 1392205
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown