MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/20/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
The surgeon inserted 2 of the ar-9400sbk speedscap 3.9 implants into the humerus, both pulled out of the bone.The case was completed using a 5.5 swivelock and a 4.75 swivelock(technique change).

• Brand Name: ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• 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: 12770405
• Report Number: 1220246-2021-03885
• Device Sequence Number: 3119383
• Product Code: MBI
• UDI-Device Identifier: 00888867356733
• UDI-Public: 00888867356733
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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): 11/08/2021

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 Expiration Date: 12/31/2025
• Device Model Number: ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
• Device Catalogue Number: AR-9400-SBK
• Device Lot Number: 12613993
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/08/2021
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown