MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPR INTERF SCRW,FULL THD; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPR INTERF SCRW,FULL THD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/28/2023, it was reported by an arthrex employee via sems that an ar-1400tc biocomposite interference screw broke.This occurred during a case, during insertion the screw was not progressing the surgeon insisted until the screw broke and the key bent.No additional information provided.Additional information requested.
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 confirmed based on the customer provided picture, which shows that a portion of the full thread cannulated bio composite interference screw, 10 x 28 mm has fractured.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.Per dfu-0111-7-rev 0 - g.Precautions - 6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.
Event or Problem Description
Additional information was provided on 12/26/2023 where it was reported by an arthrex employee that the broken screw was fully retrieved and the case was completed using another screw with the same specifications.The bone was prepared using a guidewire and a drill.The patient had good bone quality.

• Brand Name: BIO-COMPR INTERF SCRW,FULL THD
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16815007
• Report Number: 1220246-2023-06591
• Device Sequence Number: 5694811
• Product Code: MAI
• UDI-Device Identifier: 00888867016231
• UDI-Public: 00888867016231
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/14/2024

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-COMPR INTERF SCRW,FULL THD
• Device Catalogue Number: AR-1400TC
• Device Lot Number: 14923654
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• 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