MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP-SITE P-LCK 2.9X15.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/8/2024 it was reported by an arthrex employee via email that two ar-1923bc biocomposite pushlock eyelets were damaged, and the sutures got loosened.One of the ar-1923bc biocomposite pushlock eyelets ended up fully breaking while it was inside the patient, and the other biocomposite pushlock was noticed to be broken prior to insertion.The broken fragments were removed from the patient.This was discovered during a shoulder arthroscopy procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 10/28/2024: both eyelets were damages upon opening the package, however, it was not noticed on the first eyelet until it broke in the patient during insertion.For the first eyelet, the suture was placed and during insertion, the suture came out of the eyelet as it had broken.The second ar-1923bc biocomposite pushlock was opened, and it was noticed that the eyelet was damaged prior to implanting.The case was completed using another ar-1923bc biocomposite pushlock.The case was not delayed.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted an ar-1923bc biocomposite pushlock eyelet had broken off the tip of the device.It was further noted that the threaded tip of the shaft was damaged.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.".

• Brand Name: BIO-COMP-SITE P-LCK 2.9X15.5MM
• 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: 20461749
• Report Number: 1220246-2024-08159
• Device Sequence Number: 8811286
• Product Code: MAI
• UDI-Device Identifier: 00888867023017
• UDI-Public: (01)00888867023017(11)240507(17)280430(10)15244600
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K173240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2025

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: BIO-COMP-SITE P-LCK 2.9X15.5MM
• Device Catalogue Number: AR-1923BC
• Device Lot Number: 15244600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: Not provided; 06/11/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/08/2024; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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