MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; BONE FIXATION SCREW/PLATE

Model Number	TENO SCRW,BIO-COMP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a s/l ligament reconstruction surgery the screwdriver broken off in the screw.The surgery was finished successfully with a different device (fiber tape).The surgical procedure had to be changed to an open technique on both sides and a knotted fibertape.It was not necessary to do a second surgery.***update avoe 14-dec-2023 it was confirmed that the drill-bit from the kit ar-1530ds was used to prepare the bone.The bone quality was pretty good and thus wasn't a problem.The instrument broke while drilling the teno-screw in, but the broken metal part never touched the patient.
Additional Manufacturer Narrative
The complaint allegation was confirmed.Evaluation of the customer picture attached to the complaint of an ar-1530bc biocomposite-tenodesis screw with handled inserter 3 x 8 mm.It is concluded that the tip detached/broke from the shaft driver at the weld.A more in-depth evaluation of the device history record found that 22 aql samples were tested and passed the torque requirement for a minimum of 1.8 in-lbf of torque for the driver tip specified on drawing c8796 at revision 6.Based on the information collected from the facility, the bone quality was good.The most likely cause for the reported failure can be attributed to, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: TENO SCRW,BIO-COMP
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 18443305
• Report Number: 1220246-2024-00071
• Device Sequence Number: 15174439
• Product Code: HWC
• UDI-Device Identifier: 00888867018600
• UDI-Public: 00888867018600
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K051726
• 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
• Report Date (Section B): 01/04/2024

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: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1530BC
• Device Lot Number: 15095817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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