MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTERFSCRW W/DISP SHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTERFSCRW W/DISP SHTH
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/22/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the femoral screw broke in two pieces during fixation of the anterior cruciate ligament, using the kenneth jones technique.The broken screw remains in the patient, fixing the tendon.No attempts were made to remove the broken [distal] part, the device was used anyway to complete the surgery.The proximal part of the screw was retrieved and will be returned for investigation.According to the reporter, this event poses a risk of a less stable fixation of the transplant.
Additional Manufacturer Narrative
The reported event is confirmed upon investigation of the returned product.Visual evaluation confirmed that the screw had broken in the threaded region.The screw was frayed at the site of fracture and surface damage was found throughout the screw.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: BIO-COMP INTERFSCRW W/DISP SHTH
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10379248
• Report Number: 1220246-2020-02013
• Device Sequence Number: 3145738
• Product Code: MAI
• UDI-Device Identifier: 00888867014633
• UDI-Public: 00888867014633
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: BIO-COMP INTERFSCRW W/DISP SHTH
• Device Catalogue Number: AR-1370C
• Device Lot Number: 10401592
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other