MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP INTER-FERENCE SCRW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP INTER-FERENCE SCRW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/14/2019
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 remains in the patient and 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 during an anterior cruciate ligament surgery when screwing into the tibial tunnel, the screw broke on the screwdriver, at the middle of the thread.Same problem occurred with the second implant.The broken pieces remain in the patient.The surgery was finished successfully with the same device which was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update 01-feb-2019; nothing broke off the screwdriver.Only the screw broke while it was correctly mounted on the screwdriver.The surgeon tried to put a second screw next to the femoral screw in place without success, it broke too.But he did not want to aggravate the structure that could be fragile, he gave up.The broken screws seem well fixed in the bone.But according to surgeon there is a possibility that the fixation will break, if it´s not enough, but he could not know.

• Brand Name: BIO-COMP INTER-FERENCE SCRW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8321948
• Report Number: 1220246-2019-00889
• Device Sequence Number: 1526931
• Product Code: MAI
• UDI-Device Identifier: 00888867035331
• UDI-Public: 00888867035331
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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: 02/28/2019
• Device Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 10124661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other