MAUDE Adverse Event Report: ARTHREX, INC. PERIPHERAL SCREW, NL, UNI REV, 4.5X42MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	PERIPHERAL SCREW, NL, UNI REV, 4.5X42MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/08/2019
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 the following occurred during a revision procedure to remove a competitor¿s device (arthrosurface hemi cap).After removal of the competitor¿s device a reverse total shoulder procedure was then performed.During the procedure an arthrex ar-1999hh (ratcheting handle), lot 8001640 was not ratcheting correctly and could not be used.While being used to insert a central screw, an ar-9545-t15-03 (driver shaft), lot 8001643, tip broke off in the head of the screw.The tip was not retrieved and it remains in the screw in the patient.An ar-9545-t15-02, (driver shaft), lot 8001819, was also used and it was reported that the threads of the driver were twisted when tightening the superior screw.The superior peripheral screw ar-9145-42nl, lot unknown, snapped off at the shaft and half of the screw was left in the patient unretrieved.

• Brand Name: PERIPHERAL SCREW, NL, UNI REV, 4.5X42MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8670909
• Report Number: 1220246-2019-01133
• Device Sequence Number: 291379
• Product Code: KWS
• UDI-Device Identifier: 00888867135918
• UDI-Public: 00888867135918
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K130129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/05/2019

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: PERIPHERAL SCREW, NL, UNI REV, 4.5X42MM
• Device Catalogue Number: AR-9145-42NL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/05/2019
• 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