MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 34MMCORT; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW TM,SS 3.5X 34MMCORT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2021
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 tibia and fibula osteotomy (ankle fracture) procedure (b)(6) 2021 the surgeon was inserting a 3.5 cortical screw, ar-8835-34 (lot unknown), and the head of the cortical screw broke off.The driver ar-8943-12 (lot 4751509) being used did not break, just the screw head broke off.The bone socket was prepared properly using a 2.5 drill bit (ar-8943-42) and a locking tower for preparation for screw insertion.Surgeon followed by using two t15 drivers, one on power followed by hand.The bone quality was reported to be good.The surgeon was able to use a locking screw proximal to where the broken screw was placed.The case was completed.
Additional Manufacturer Narrative
It was reported that the screw head had broken off from the screw.The reported event is confirmed upon investigation of the returned pictures.Visual evaluation identified that the screw head had disassembled completely from the screw.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces while torquing the screw.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 34MMCORT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11228598
• Report Number: 1220246-2021-02489
• Device Sequence Number: 14418395
• Product Code: HWC
• UDI-Device Identifier: 00888867047389
• UDI-Public: 00888867047389
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW TM,SS 3.5X 34MMCORT
• Device Catalogue Number: AR-8835-34
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 01/29/2021
• 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