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

Model Number	TENO SCRW,BIO-COMP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/23/2021, it was reported by a arthrex employee via e-mail that a ar-1530bc bio-composite-tenodesis inserter broke.This occurred on (b)(6) 2021 during an unknow procedure after inserting the screw into the bone socket, the inserter was broke.No additional information provided, additional information requested.
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 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 12/23/2021, it was reported by a arthrex employee via e-mail that a ar-1530bc bio-composite-tenodesis inserter broke.This occurred on (b)(6) 2021 during an unknow procedure after inserting the screw into the bone socket, the inserter was broke.No additional information provided, additional information requested.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the distal tip had broken off, with the drive geometry no longer present.Additionally, it was identified that approximately 23.38mm of the shaft had fragmented.Device testing could not be performed due to the damaged of the device.The cause of this event is undetermined; however, a probable cause can be attributed to prying/leveraging the driver tip within the screw hex during insertion.The method used to prepare the bone during the procedure, as well as the bone quality encountered, were not provided.

• Brand Name: TENO SCRW,BIO-COMP
• Common Device Name: SCREW, FIXATION, BONE
• 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: 13225893
• Report Number: 1220246-2022-04281
• Device Sequence Number: 3734320
• Product Code: HWC
• UDI-Device Identifier: 00888867018600
• UDI-Public: 00888867018600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/28/2022

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 Expiration Date: 04/30/2025
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1530BC
• Device Lot Number: 13288354
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown