MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T8, NON-RETAINING, AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T8, NON-RETAINING, AO
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
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 the surgeon was powering in the 2.4 screw on stryker 600 power into the cuboid.The ar-18700-55 (lot 1391944) driver tip broke off inside the variable angle locking screw head.The surgeon tried to pry it out with a dental pick and it seemed to be cold welded into the screw head.The surgeon made note of this in his dictation for future removal purposes.The procedure was finished and no harm was caused to the patient.The procedure was completed successfully and the driver will be returned for evaluation.
Additional Manufacturer Narrative
Complaint confirmed, the drive feature tip is twisted and broken.The device was found to meet specifications.Likely causes of the event include continually applying torque when the device is not moving, shallow driver engagement depth, prying/leveraging the device during use.

• Brand Name: DRIVER SHAFT, T8, NON-RETAINING, AO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10516869
• Report Number: 1220246-2020-02150
• Device Sequence Number: 3155410
• Product Code: LXH
• UDI-Device Identifier: 00888867316287
• UDI-Public: 00888867316287
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 10/13/2020

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, T8, NON-RETAINING, AO
• Device Catalogue Number: AR-18700-55
• Device Lot Number: 1391944
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other