MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T4, SELF RETAINING,MINI AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T4, SELF RETAINING,MINI AO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
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 during a procedure the ar-18716p-10 plate was damaged during the attempted cut and the tip of the ar-18700-09 driver broke off into the screw head.Additional information provided 6/8/21: the broken tip of ar-18700-09 was unable to be removed from the screw head.The driver tip broke completely flush within the screw head and the surgeon was unable to remove it.The case was completed by removing the entire screw from the patient using a needle nose pliers, and using a less optimal plate because the most optimal plate we needed was bent during an attempted cut.Both devices were discarded.

• Brand Name: DRIVER SHAFT, T4, SELF RETAINING,MINI AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11991278
• Report Number: 1220246-2021-03276
• Device Sequence Number: 3564727
• Product Code: LXH
• UDI-Device Identifier: 00888867313781
• UDI-Public: 00888867313781
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 06/14/2021

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: DRIVER SHAFT, T4, SELF RETAINING,MINI AO
• Device Catalogue Number: AR-18700-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1