MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,PEEK,VENT; BONE FIXATION SCREW/PLATE

Model Number	TENO SCRW,PEEK,VENT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the implant was found to be broken.The surgeon reported that there was no harm for patient, operator or third party.The surgery was finished successfully with a new device.It was not necessary to switch the surgical technique or do a second surgery.(b)(6) 2021 update dw further information was provided that the implant cracked while the surgeon tried to implant it.Nothing broke off from the screw.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1547ps peek anchor was received for investigation.Visual inspection identified that the distal-most thread of the peek implant had broken and unraveled.The method used to prepare the bone during the procedure, as well as the bone quality encountered, were not recorded.As such, probable causes can be attributed to improper bone preparation and/or prying/leveraging the implant during insertion.

• Brand Name: TENO SCRW,PEEK,VENT
• 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: 18296601
• Report Number: 1220246-2023-09317
• Device Sequence Number: 7081684
• Product Code: HWC
• UDI-Device Identifier: 00888867018785
• UDI-Public: 00888867018785
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 12/08/2023

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 Expiration Date: 01/31/2025
• Device Model Number: TENO SCRW,PEEK,VENT
• Device Catalogue Number: AR-1547PS
• Device Lot Number: 10614059
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• 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