MAUDE Adverse Event Report: ARTHREX, INC. PEEK TENO SCRW,PEEK,VENT; SCREW, FIXATION, BONE

Model Number	PEEK TENO SCRW,PEEK,VENT
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/15/2019
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 a scapholunate dissection repair, the surgeon fixed the graft tendon and the tape on the bone with a peek tenodesis screw, ar-1540ps.When he tried to remove the driver, the removal was difficult.The surgeon had to pull it out with pliers and a hammer.At this time, the bones around the fixation site were broken.The procedure was completed by using another manufacturer's devices.No further information provided.Further information requested.Additional information provided 5/21/2019: the bone fractured when the screw was pulled from the bone.No part of the screw of the driver broke.The surgeon originally planned to repair the scapholunate with only three anchors but because the bone was fractured, he had to use many more anchor from another manufacturer to sew the tissue and bone together.The fracture led the patient to a cast for 8 weeks post-op.There were no x-rays taken.
Event or Problem Description
It was reported that during a scapholunate dissection repair, the surgeon fixed the graft tendon and the tape on the bone with a peek tenodesis screw, ar-1540ps.When he tried to remove the driver, the removal was difficult.The surgeon had to pull it out with pliers and a hammer.At this time, the bones around the fixation site were broken.The procedure was completed by using another manufacturer's devices.No further information provided.Further information requested.Additional information provided 5/21/2019: the bone fractured when the screw was pulled from the bone.No part of the screw of the driver broke.The surgeon originally planned to repair the scapholunate with only three anchors but because the bone was fractured, he had to use many more anchor from another manufacturer to sew the tissue and bone together.The fracture led the patient to a cast for 8 weeks post-op.There were no x-rays taken.Additional information provided 10/2/2019: the graft diameter was 2-3mm after whipstitching.The drill for the dx swivelock 3.5mm*8.5mm was used.The surgeon did not try to back the screw out, he tried to pull out the driver.
Additional Manufacturer Narrative
Additional information obtained 10/2/19 has been added to the event description.Complaint confirmed, the implant appears to have deformed and twisted around the driver from the distal end during insertion, becoming stuck.It is stated a 3.5mm drill was used.Per surgical technique, a 4 or 4.5 mm drill should be used to prep the bone for the 4mm implant ar-1540ps.The most likely cause is improper bone preparation.

• Brand Name: PEEK TENO SCRW,PEEK,VENT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8699376
• Report Number: 1220246-2019-01141
• Device Sequence Number: 1993153
• Product Code: HWC
• UDI-Device Identifier: 00888867018747
• UDI-Public: 00888867018747
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (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): 10/10/2019

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: 08/31/2023
• Device Model Number: PEEK TENO SCRW,PEEK,VENT
• Device Catalogue Number: AR-1540PS
• Device Lot Number: 10238478
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other