MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW,FULL THD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTERFSCRW,FULL THD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cruciate ligament plastic the thread of the implant broke off when it was inserted.Here was no harm for patient, operator or third party reported.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.11-may-2023 update dw further information were provided that the broken pieces were retrieved out of the patient.
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: the complaint allegation was confirmed.One unpackaged aar-1370tc was returned for investigation.The returned device was visually inspected, and it was noted that the screw was damaged.The thread side profile is missing/damaged, as well a missing profile was observed at the proximal and distal end of the screw.It is unknown whether the quality or quantity of the bone.The most likely cause for the reported failure is a user error per dfu-0111 rev.1.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.

• Brand Name: BIO-COMP INTERFSCRW,FULL THD
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 17077783
• Report Number: 1220246-2023-06844
• Device Sequence Number: 14015852
• Product Code: MAI
• UDI-Device Identifier: 00888867014725
• UDI-Public: 00888867014725
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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: 09/30/2026
• Device Model Number: BIO-COMP INTERFSCRW,FULL THD
• Device Catalogue Number: AR-1370TC
• Device Lot Number: 15009804
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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