MAUDE Adverse Event Report: ARTHREX, INC. T15 HEXALOBE, ISO, CANN.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	T15 HEXALOBE, ISO, CANN.
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/25/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a procedure, when the surgeon was implanting the screw and tip broke off.No harm to the patient.
Additional Manufacturer Narrative
Complaint confirmed, the tip was found to be broken.Approximately 1/8 in broke off.The only relevant feature that is undamaged and could be measured met drawing specifications.The cause of the event is undetermined, however likely causes include user-applied mechanical forces.

• Brand Name: T15 HEXALOBE, ISO, CANN.
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11991331
• Report Number: 1220246-2021-03281
• Device Sequence Number: 11653733
• Product Code: LXH
• UDI-Device Identifier: 00888867263765
• UDI-Public: 00888867263765
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T15 HEXALOBE, ISO, CANN.
• Device Catalogue Number: AR-8750-03
• Device Lot Number: 011905
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1