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

Model Number	SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a glenoid labrum surgery the device broke.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information was provided.Update (b)(6) 2023: during a glenoid labrum surgery, the anchors broke.Update (b)(6) 2023: the anchors broke during insertion.It was stated that all broken parts were successfully removed.
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
The complaint allegation is not confirmed.The broken pieces or devices were not returned for evaluation.No pictures were provided of the broken anchor.However, a visual inspection revealed, no issues with the sealed devices when they were opened.The method of bone preparation and the quality of the bone encountered were not provided.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE 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: emily shafer ; 8009337001
• MDR Report Key: 18138935
• Report Number: 1220246-2023-08738
• Device Sequence Number: 6467664
• Product Code: MAI
• UDI-Device Identifier: 00888867023239
• UDI-Public: 00888867023239
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101679
• 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): 08/19/2024

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: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• Device Catalogue Number: AR-1926BC
• Device Lot Number: 15019230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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