MAUDE Adverse Event Report: ARTHREX, INC. BIO-INTERFERENCE SCREW; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-INTERFERENCE SCREW
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2019
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 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 acl procedure, the screw would only enter halfway into the bio-interference screw, ar-1370b.The surgeon tried 2 other screwdrivers and this did not work.The graft was fixed into the tibial tunnel with an interference screw and the screw entered was divided halfway outside and inside bone.No further information provided.Further information requested.Additional information provided on (b)(6) 2019: the procedure being performed was a repair of anterior cruciate ligament.Bone quality was reported to be hard.The piece that broke was not fully retrieved.The case was completed by using a second screw of a larger diameter to fix the graft in the tibial area.The surgeon had to switch to another surgical technique which was a semitendinosus autologous graft used with interference fixation in the tibia and femur.
Additional Manufacturer Narrative
Complaint confirmed.During visual evaluation it was revealed that the first bio-interference screw broke off at the eighth thread prior to receipt for investigation, and the distal end of the screw was found to be twisted, which is consistent with breakage during insertion.The second bio-interference screw had no damage.Also during device functioning, both ar-1370b screws were functioned with an ar-1386 driver, and would not advance down the driver.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-INTERFERENCE SCREW
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8769047
• Report Number: 1220246-2019-01193
• Device Sequence Number: 13911489
• Product Code: MAI
• UDI-Device Identifier: 00888867014626
• UDI-Public: 00888867014626
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: BIO-INTERFERENCE SCREW
• Device Catalogue Number: AR-1370B
• Device Lot Number: 10129176
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 07/29/2019
• 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