MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW FT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/03/2018
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 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 shoulder arthrodesis two screws broke.Update swit 04 july 2018: the screws were broken during insertion.An attempt was made to retrieve the broken pieces but it was not possible to retrieve the broken fragments.They will remain inside the patient.The surgery was finished successfully with a new device with the same part no.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed the tapered tips of both screws had broken off at the thread before deploying from the drivers.The devices met all material and dimensional specifications as received.The most likely cause(s) of this type of event include not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.

• Brand Name: SUTR ANCH,CRKSCRW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7713352
• Report Number: 1220246-2018-00561
• Device Sequence Number: 904437
• Product Code: HWC
• UDI-Device Identifier: 00888867284951
• UDI-Public: 00888867284951
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2018

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 Expiration Date: 04/30/2023
• Device Model Number: SUTR ANCH,CRKSCRW FT
• Device Catalogue Number: AR-1928SF-45-1
• Device Lot Number: 10209521
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/20/2018
• Patient Sequence Number: 1