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	Insufficient Information (4580)
Date of Event	02/24/2021
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, that during a proximal phalanx fracture of the 2nd finger repair procedure, as the surgeon was inserting the screw when the tip of the ar-18700-09, drive shaft broke.The broken piece was removed.The surgeon used an ar-18700-29, drive shaft, for insertion of the last screw, the surgeon could feel the tip of the driver was twisting and backed off removing the ar-18700-29.The case was completed leaving the screw not fully seated.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-18700-29, batch 1391940 driver shaft was received for investigation.Visual inspection through the use of micro-vu id: 654 identified that the drive geometry at the distal tip was both twisted and broken.Micro-vu measurements revealed that approximately 0.09620" of the tip remained, with design tolerances outlining the tip length as measuring between 0.125"±.001".The whorl pattern visualized under magnification across the surface of the drive geometry indicated that the tip broke as the device was being torqued.Material analysis testing identified that the returned ar-18700-29 driver shaft met composition specifications.Based on the observed condition of the distal tip and all findings noted, this event is most likely the result of over-torquing the driver during use.

• 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: 11437296
• Report Number: 1220246-2021-02697
• Device Sequence Number: 5170117
• Product Code: LXH
• UDI-Device Identifier: 00888867303553
• UDI-Public: 00888867303553
• 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,Followup
• Report Date (Section B): 06/02/2021

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: DRIVER SHAFT, T4, NON-RETAINING, MINI AO
• Device Catalogue Number: AR-18700-29
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/02/2021
• Patient Sequence Number: 1