MAUDE Adverse Event Report: ARTHREX, INC. DRIVER SHAFT, T-15, LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRIVER SHAFT, T-15, LONG
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/24/2019
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 requested/is expected but has 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 universe reverse procedure the tip of the screwdriver broke off.The screw was already fixed tightly.The tip still remains in the screw in patient.The surgery was finished successfully with the same device which was used anyway.It was not necessary to switch the surgical technique or do a second surgery.Update 02-may-2019: the remaining fragment is fixed and cannot move inside patient.There are no consequences for patient.
Additional Manufacturer Narrative
Complaint confirmed, the drive was found to be missing the distal end and to be twisted.The most likely cause(s) of this type of event include continually applying torque when the implant is not properly aligned, leveraging, or torquing while leveraging the device.It was not reported whether or not a torque indicating adapter was used with this device, which is recommended to prevent over-torquing that can lead to driver damage.

• Brand Name: DRIVER SHAFT, T-15, LONG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8636819
• Report Number: 1220246-2019-01104
• Device Sequence Number: 19400189
• Product Code: LXH
• UDI-Device Identifier: 00888867225176
• UDI-Public: 00888867225176
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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, T-15, LONG
• Device Catalogue Number: AR-9545-T15-03
• Device Lot Number: 8001817
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other