MAUDE Adverse Event Report: ARTHREX, INC. CANN SCRW 3.75X 38MMFULLY THRDED; SCREW, FIXATION, BONE

Model Number	CANN SCRW 3.75X 38MMFULLY THRDED
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/02/2020
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 latarjet procedure, after pre-drilling and upon insertion of the ar-7000-38ft, the head of the screw broke off.The remaining part could not be removed from the patient.The fixation was reported to have been adequate and bone quality was reported to be good according to the surgeon.The guidewire and cannulated drill had been used to prep the bone prior to insertion.Screw head is available to return for evaluation.
Additional Manufacturer Narrative
Complaint confirmed, one head of a screw was received.Measurement of the returned screw head shows approximately 4.1mm of the proximal end of the screw was returned.Most likely cause of this failure is over-torquing of the screw, during insertion or improper insertion angle.

• Brand Name: CANN SCRW 3.75X 38MMFULLY THRDED
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10184914
• Report Number: 1220246-2020-01917
• Device Sequence Number: 19515338
• Product Code: HWC
• UDI-Device Identifier: 00888867041110
• UDI-Public: 00888867041110
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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 Model Number: CANN SCRW 3.75X 38MMFULLY THRDED
• Device Catalogue Number: AR-7000-38FT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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