MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-S-TAK,SM JNT; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,BIO-S-TAK,SM JNT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
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
On 10/17/2023, it was reported by an arthrex subsidiary employee via email that an ar-8934bnf small joint bio-suturetak anchor broke.All fragments were removed from inside the patient and the case was completed using another ar-8934bnf small joint bio-suturetak.This was discovered during a modified brostrom procedure on (b)(6) 2023.There was no case delay and additional anesthesia was not administered.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is not confirmed.Visual evaluation identified that the driver was received without broken pieces of the bio-suturetak or suture.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH,BIO-S-TAK,SM JNT
• 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: 18129269
• Report Number: 1220246-2023-08704
• Device Sequence Number: 12419135
• Product Code: HWC
• UDI-Device Identifier: 00888867050372
• UDI-Public: 00888867050372
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050749
• 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): 08/26/2024

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 Expiration Date: 09/30/2026
• Device Model Number: SUTR ANCH,BIO-S-TAK,SM JNT
• Device Catalogue Number: AR-8934BNF
• Device Lot Number: 15010977
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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