MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 26MMCORT; PLATE, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.0MMX 26MMCORT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that during inserted of the ar-8933-26 low profile screw, the head of the screw broke off and became stuck to the driver.The surgeon was not using power as this was done by hand after a few turns.The remaining screw was removed and the case was completed by using a new ar-8933-26.
Additional Manufacturer Narrative
Complaint was confirmed.A fracture was observed on the underside of the screw.A critical dimensional measurement was done on the head of the returned device.The device met all specifications as received.The cause is undetermined; however the most likely cause for this event to occurred is by over torqued the screw, when inserting into the plate and/or hard bone.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 26MMCORT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12658402
• Report Number: 1220246-2021-03797
• Device Sequence Number: 4489462
• Product Code: HRS
• UDI-Device Identifier: 00888867049666
• UDI-Public: 00888867049666
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 26MMCORT
• Device Catalogue Number: AR-8933-26
• Device Lot Number: 031820
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown