MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 5th december 2024, it was reported by an arthrex employee via email that for an ar-1922bc, suture anchor, biocomposite pushlock anchor eyelet broke during implantation.This was detected during a rotator cuff repair surgery on (b)(6) 2024.Ar-1922p was used to prepare bone socket.The eyelet of the implant broke during implantation.No fragments were left in the patient.Procedure was successfully completed with no patient harm and no secondary procedure needed by using another product ar-2324bcc instead.
Additional Manufacturer Narrative
Additional information: b3, d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-1922bc suture anchor, biocomposite pushlock 4.5 x 24 mm serial/batch number (b)(6) was received for evaluation.Visual inspection revealed that the eyelet was broken off and the anchor is no longer attached to the shaft's tip.The evaluation of the driver and driver handle found not issues.Functional testing was performed by moving the inner shaft to check for resistance and not problem was found.The most likely cause of the reported failure is user error, specifically improper bone preparation, misalignment of the insertion and/or applying excessive force on the device during use.Directions for use direction for use.Dfu-0087.Corkscrew®, pushlock®, and swivelock® suture anchors.Precautions: 4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.5.Pushlock and swivelock suture anchors only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during final advancement of the anchor body.

• Brand Name: SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
• 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: 21048626
• Report Number: 1220246-2024-09157
• Device Sequence Number: 12864147
• Product Code: MAI
• UDI-Device Identifier: 00888867022874
• UDI-Public: (01)00888867022874(11)240326(17)280229(10)15225276
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082810
• 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): 03/28/2025

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: SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
• Device Catalogue Number: AR-1922BC
• Device Lot Number: 15225276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2024
• 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