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

Model Number	BIO-COMP INTERFSCRW,FULL THD
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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 reconstruction surgery with patellar tendon the device broke during implantation.No broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.A button was used instead of the screw for tibial fixation.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed, a fragment of ar-1380tc was returned.The fragment is heavily deformed and no feature could be measured due to the deformation and damage observed.The cause of the event remains undetermined, however likely causes include improper bone prep; prying/leveraging the device during insertion; shallow driver engagement depth.

• 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
• MDR Report Key: 12434028
• Report Number: 1220246-2021-03602
• Device Sequence Number: 4739482
• Product Code: MAI
• UDI-Device Identifier: 00888867015357
• UDI-Public: 00888867015357
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 12/31/2023
• Device Model Number: BIO-COMP INTERFSCRW,FULL THD
• Device Catalogue Number: AR-1380TC
• Device Lot Number: 10565921
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1