MAUDE Adverse Event Report: ARTHREX, INC. DRV SFT,T8 HEXALOBE CANN,STR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	DRV SFT,T8 HEXALOBE CANN,STR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
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 surgery/ treatment the screwdriver did break off while a simple metal removal.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully, the screw has been taken off with a bigger drill and a plier, because of the chance of the surgical technique the time of the surgery was extended with 40 additional minutes.It was not necessary to do a second surgery.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8737-25, batch 1392025 was received for investigation.Visual inspection identified that the distal tip of the drive geometry had broken.No fragments were returned for analysis.Further inspection revealed that the breakage site was noticeably twisted, indicating that the device broke under torsion.The observed condition is consistent with breakage due to over-torquing/over-engaging the driver during use.

• Brand Name: DRV SFT,T8 HEXALOBE CANN,STR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12570775
• Report Number: 1220246-2021-03730
• Device Sequence Number: 11739519
• Product Code: LXH
• UDI-Device Identifier: 00888867046207
• UDI-Public: 00888867046207
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRV SFT,T8 HEXALOBE CANN,STR
• Device Catalogue Number: AR-8737-25
• Device Lot Number: 1392025
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other