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	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/02/2024, it was reported by an arthrex subsidiary employee via email that an ar-8934bnf suture anchor pulled out during insertion.The case was completed using another ar-8934bnf with unknown lot numbers.
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
Complaint confirmed.One unpackaged ar-8934bnf serial/batch number 15019683 was received for evaluation.No functional test applies to this device.Visual evaluation of the driver shaft and handle found not issues.An inspection of the 3mm bio found that the implant lost the geometry of the thread.The implant was deformed.No damage was observed on the sutures.Per customer information, the patient's bone quality was described as "lower than moderate" according to dfu-0054 at revision 0.C.Contraindications.1.Insufficient quantity or quality of bone.The most likely cause(s) for the reported failure can be a user error, improper bone preparation, or misaligned insertion.Per dfu-0054 at revision 0.G.Precautions.1.Surgeons must apply their professional judgment when determining the appropriate suture-anchor type and size based on the specific indication, preferred surgical technique, and patient history.5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.

• 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: 18552963
• Report Number: 1220246-2024-00453
• Device Sequence Number: 17743087
• 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): 05/14/2024

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: SUTR ANCH,BIO-S-TAK,SM JNT
• Device Catalogue Number: AR-8934BNF
• Device Lot Number: 15019683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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