MAUDE Adverse Event Report: ARTHREX, INC. BIO-COM INTERFERENCE SCREW, TAPERED TIP; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COM INTERFERENCE SCREW, TAPERED TIP
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
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
It was reported that during a knee arthroscopy screwing the device into the bone was impossible.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.Update swit 26-apr-2024: screwing into the bone was impossible, because the thread was damaged.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Upon visual evaluation found that the base of the interference screw had cracked.No damaged threads were found.Functional testing was performed and device worked as required.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.The most likely cause can be attributed misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the screw during insertion.

• Brand Name: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• 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: 19378324
• Report Number: 1220246-2024-03688
• Device Sequence Number: 7538286
• Product Code: MAI
• UDI-Device Identifier: 00888867014008
• UDI-Public: 00888867014008
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K071176
• 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): 09/12/2024

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 Expiration Date: 01/31/2026
• Device Model Number: BIO-COM INTERFERENCE SCREW, TAPERED TIP
• Device Catalogue Number: AR-1360C
• Device Lot Number: 14922928
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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