MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-FIX RCG STERILE PAC; ARTHROSCOPE

Model Number	014771
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the t-fix was ready to be used, plugged on the power tool.The t-fix broke at full speed, entering the coracoid process.The tip of the male part broke, just under the connection of male/female parts.Broken piece was removed from the patient.Procedure was completed with a back-up device.No patient injury reported.
Additional Manufacturer Narrative
One 014771 t-fix rcg sterile pac 2mm sterile t fix rcg drill with hub returned.The complaint states: ¿it was reported that the t-fix was ready to be used, plugged on the power tool.The t-fix broke at full speed, entering the coracoid process.The tip of the male part broke, just under the connection of male/female parts.Broken piece was removed from the patient.Procedure was completed with a back-up device.¿ there are scratches and dings on the blade flutes.The drill shaft is slightly bowed and has spiral wear bands.There are also random scratches in other locations.The drill¿s tail portion has been fractured from over torque at the location where the 2mm drill hub is permanently attached.Per the ifu: ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.¿ no root cause associated with the manufacture of this device was established.No further investigation warranted.

• Brand Name: T-FIX RCG STERILE PAC
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7376039
• Report Number: 1219602-2018-00378
• Device Sequence Number: 11011198
• Product Code: HRX
• UDI-Device Identifier: 03596010446114
• UDI-Public: (01)03596010446114(17)220814(10)50677114
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K925573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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 Expiration Date: 08/14/2022
• Device Model Number: 014771
• Device Catalogue Number: 014771
• Device Lot Number: 50677114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1