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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/31/2023, it was reported by an arthrex employee via email that (qty.2) ar-8934bnf small joint bio-suturetak anchors pulled out.This was discovered during an atfl procedure on (b)(6) 2023.The case was completed by using a new ar-8934bnf.Additional information provided 08/09/2023: it was reported that a 10 min delay occurred with no additional anesthesia.Some pieces of the implant were broken and the surgeon retrieved it and discarded it.The case was complete with an ar-8934bnf.
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
Additional information: d9, g3, h6 complaint is confirmed.Visual inspection identified that the implant 3.0 mm bio-suture tak of the small joint bio-suturetak® with needles, 3.0 mm, with 2x #0 fiberwire® had pulled out from the shaft.Functional testing was not performed due to the damage to the device.The most likely cause can be attributed to improper bone preparation, excessive force being used or prying/leveraging the screw 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: 17625031
• Report Number: 1220246-2023-07644
• Device Sequence Number: 14973458
• 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): 06/21/2024

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: 12/31/2025
• Device Model Number: SUTR ANCH,BIO-S-TAK,SM JNT
• Device Catalogue Number: AR-8934BNF
• Device Lot Number: 14918292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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