MAUDE Adverse Event Report: ARTHREX, INC. ES TROCH NAIL, LEFT, 10MMX39CMX130; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	ES¿ TROCH NAIL, LEFT, Ø10MMX39CMX130°
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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.
Event or Problem Description
It was reported by an arthrex sales representative that a facility has experienced frequent instances of the galileo es nail breaking at the shaft hole targeted by the jig.The assumed part number based on photos provided is 1066-395 and a second complaint line has been entered to represent the previous nails that failed where part number is unknown.
Additional Manufacturer Narrative
It was reported that the device broke at the shaft hole.Visual evaluation identified that the nail was broken at the shaft hole position.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.The reported event is confirmed based on the investigation of the returned pictures.

• Brand Name: ES TROCH NAIL, LEFT, 10MMX39CMX130
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11328110
• Report Number: 1220246-2021-02590
• Device Sequence Number: 2660667
• Product Code: HSB
• UDI-Device Identifier: 00848665015386
• UDI-Public: 00848665015386
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120148
• 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,Followup
• Report Date (Section B): 05/10/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ES¿ TROCH NAIL, LEFT, Ø10MMX39CMX130°
• Device Catalogue Number: 1066-395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other