MAUDE Adverse Event Report: ARTHREX, INC. CANN SCRW 3.75X 36MMFULLY THRDED; SCREW, FIXATION, BONE

Model Number	CANN SCRW 3.75X 36MMFULLY THRDED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
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 that an ar-7000-36ft screw broke off during a shoulder repair while it was being implanting.All was retrieved.It was replaced with another screw from the same part / lot and that worked fine and the case was completed with no further issues.The patient is fine to date.
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 that an ar-7000-36ft screw broke off during a shoulder repair while it was being implanting.All was retrieved.It was replaced with another screw from the same part / lot and that worked fine and the case was completed with no further issues.The patient is fine to date.

• Brand Name: CANN SCRW 3.75X 36MMFULLY 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: 12896572
• Report Number: 1220246-2021-04013
• Device Sequence Number: 14793851
• Product Code: HWC
• UDI-Device Identifier: 00888867041080
• UDI-Public: 00888867041080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/30/2021

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: CANN SCRW 3.75X 36MMFULLY THRDED
• Device Catalogue Number: AR-7000-36FT
• Device Lot Number: 13855338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 11/30/2021
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown