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	10/24/2018
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 requested/is expected but has not returned for evaluation.The 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 a knee surgery the screw was broken off.The broken part was not retrieved from the patient and remains in the bone.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.Update 31, oct, 2018: the broken fragment is tibially fixed in the bone and can not move.No x-ray is available.The broken part remains in the bone, no further measures were taken.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed that the bio-composite screw had broken off at the fourth thread prior to receipt for investigation.Complainant's event is most likely caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation or flexing the joint during insertion.Per product directions for use (dfu-0111), it is important to completely seat the screwdriver to prevent potential screw fracture during insertion.

• 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: 8065748
• Report Number: 1220246-2018-00743
• Device Sequence Number: 19368366
• Product Code: MAI
• UDI-Device Identifier: 00888867035331
• UDI-Public: 00888867035331
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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 Model Number: BIO-COMP INTER-FERENCE SCRW
• Device Catalogue Number: AR-5028C-09
• Device Lot Number: 10191786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other