MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, PEEK, NON-COLLAGEN COATED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IB KIT, PEEK, NON-COLLAGEN COATED
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the 2, 7mm anchor bent when placed in the drill channel.There was no harm for patient, operator or third party reported.No further information received.Update avoe 31-aug-2023 it was confirmed that the error occurred during a sg-bandaugmentation surgery.After consultation with the surgeon in charge, the metal device on the 3.5 mm swivelock anchor (which is included in the kit) was bent by levering it too hard.The swivelock anchor itself was not damaged.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
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
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 most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.

• Brand Name: IB KIT, PEEK, NON-COLLAGEN COATED
• 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: 17825248
• Report Number: 1220246-2023-07997
• Device Sequence Number: 6138294
• Product Code: MAI
• UDI-Device Identifier: 00888867318120
• UDI-Public: 00888867318120
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 02/27/2025

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: IB KIT, PEEK, NON-COLLAGEN COATED
• Device Catalogue Number: AR-1778P-CP
• Device Lot Number: 15072107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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