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	08/26/2020
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 during a metacarpal fracture procedure the surgeon was using an ar-18700-29, t-4 driver shaft (lot 1391940), to screw a variable ankle locking screw into a 1.4 z-plate.The tip of the driver shaft broke off in the screw head.The surgeon was unable to remove the tips from the screw head.The screw was sitting flush with the plate.No additional incisions or change of techniques were needed.
Additional Manufacturer Narrative
The reported event is confirmed upon investigation of the returned product.Visual evaluation of the provided pictures identified that the driver had fractured off into the associated screw head.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• 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: 10516780
• Report Number: 1220246-2020-02149
• Device Sequence Number: 3316656
• Product Code: LXH
• UDI-Device Identifier: 00888867303553
• UDI-Public: 00888867303553
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/17/2020

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?: Yes
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 09/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other