MAUDE Adverse Event Report: ARTHREX, INC. CANN SCRW 3.75X 32MMFULLY THRDED; SCREW, FIXATION, BONE

Model Number	CANN SCRW 3.75X 32MMFULLY THRDED
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2022
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 1/28/2022, it was reported by a sales representative via phone that an ar-7000-32ft screw broke when the surgeon was attempting to tighten it.Surgeon was able to retrieve the broken piece and completed case using another ar-7000-32ft screw.This was discovered during a scaphoid bone procedure on (b)(6) 2022.

• Brand Name: CANN SCRW 3.75X 32MMFULLY THRDED
• Common Device Name: SCREW, 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: 13455810
• Report Number: 1220246-2022-04383
• Device Sequence Number: 13780331
• Product Code: HWC
• UDI-Device Identifier: 00888867041028
• UDI-Public: 00888867041028
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• 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
• Report Date (Section B): 02/04/2022

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: CANN SCRW 3.75X 32MMFULLY THRDED
• Device Catalogue Number: AR-7000-32FT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown