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	Insufficient Information (4580)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, all three drive features were twisted.One of the three was also broken and missing about 1/8 in.It is stated no torque indicating device was used, which is recommended to prevent damaging the device.A likely cause of the event is continually applying torque.
Event or Problem Description
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, all three drive features were twisted.One of the three was also broken and missing about 1/8 in.It is stated no torque indicating device was used, which is recommended to prevent damaging the device.A likely cause of the event is continually applying torque.
Additional Manufacturer Narrative
Complaint confirmed, all three drive features were twisted.One of the three was also broken and missing about 1/8 in.It is stated no torque indicating device was used, which is recommended to prevent damaging the device.A likely cause of the event is continually applying torque.

• 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: 11761563
• Report Number: 1220246-2021-03006
• Device Sequence Number: 4015754
• Product Code: LXH
• UDI-Device Identifier: 00888867225176
• UDI-Public: 00888867225176
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRIVER SHAFT, T-15, LONG
• Device Catalogue Number: AR-9545-T15-03
• Device Lot Number: 8001940
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1