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

Model Number	DRIVER SHAFT, T4, NON-RETAINING, MINI AO
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/04/2020
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 while inserting a 1.4 locking screw into the 1.4 cage screw the driver, ar-18700-29, broke off in the screw head.Reporter states patient was not harmed.Additional information obtained 6/8/20: the lot number of the ar-18700-29 was lot 1391940.Procedure was a phalanx fracture.The screwdriver tip was left in the head of the screw, unretrieved inside the patient.The screw as fully seated.The surgeon used another screw driver that was in the instrument set to complete the procedure.The ar-18700-29 was discarded by the facility before the sales rep was able to retrieve it for evaluation.Device will not be returned.

• Brand Name: DRIVER SHAFT, T4, NON-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: 10212011
• Report Number: 1220246-2020-01924
• Device Sequence Number: 14270649
• Product Code: LXH
• UDI-Device Identifier: 00888867303553
• UDI-Public: 00888867303553
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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: DRIVER SHAFT, T4, NON-RETAINING, MINI AO
• Device Catalogue Number: AR-18700-29
• Device Lot Number: 1391940
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other