MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
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 an anterior cruciate ligament surgery the screw did not hold during insertion.The front threads turned off directly.There was no harm for patient, operator or third party.The surgery was finished successfully with a different part number, ar-5035tc-09.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-5035tc-10/ batch 15162964 was received for investigation.Upon visual evaluation under a magnifier, it was noted that the hex and the distal tip of the device were damaged.The threads of the device were also stripped.Functional testing revealed that that the critical measurements were within tolerance.Functional testing revealed that the critical measurements were within tolerance.The device was measured with caliper id: (b)(6) and the critical measurements were within tolerance.The expected length was expected at 1.37 ±.01 and it measures at 1.37in.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-COMP INTERFSCRW CAN-DELTATPR 10X35MM
• 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: 19221505
• Report Number: 1220246-2024-02677
• Device Sequence Number: 12554191
• Product Code: MAI
• UDI-Device Identifier: 00888867035515
• UDI-Public: 00888867035515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: BIO-COMP INTERFSCRW CAN-DELTATPR 10X35MM
• Device Catalogue Number: AR-5035TC-10
• Device Lot Number: 15162964
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2023
• 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