MAUDE Adverse Event Report: ARTHREX, INC. PEEK, SWIVELOCK FT, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK, SWIVELOCK FT, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
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 02/5/2024, it was reported by an arthrex subsidiary employee via email that an ar-2324pct peek swivelock anchor broke during insertion.The case was completed using another ar-2324pct peek swivelock.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b.5: event updated.G.3: follow-up information received.H.6: updated.
Event or Problem Description
Additional information received on 2/22/2024: this was discovered during a shoulder arthroscopy procedure, and it was completed using an ar-2323pslc peek swivelock.All the broken fragments were successfully removed from inside the patient.The case was not delayed, and additional anesthesia was unnecessary.The patient suffered not negative effects.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The method used to prepare the bone, was not provided.The most likely cause can be attributed to improper bone preparation; misaligned insertion; or prying/leveraging the device during use.

• Brand Name: PEEK, SWIVELOCK FT, 4.75X19.1MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 18750294
• Report Number: 1220246-2024-01059
• Device Sequence Number: 3729078
• Product Code: MAI
• UDI-Device Identifier: 00888867098107
• UDI-Public: 00888867098107
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101823
• 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,Followup
• Report Date (Section B): 10/29/2024

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: PEEK, SWIVELOCK FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324PCT
• Device Lot Number: 15081107
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/22/2024; 10/16/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/13/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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