MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCOPIC CANN 7MM; BIT, DRILL

Model Number 7209008

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

It was reported that, during an unknown procedure, the 7mm flexible drill broke while beginning to drill the tunnel.It is unknown if a back-up device was available or if there was a delay in the scheduled surgery.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h3,h6: one 7209008 drill flexible endoscopic cann 7mm, intended for use in treatment, has not been returned for evaluation.This is a six-year-old reusable device.Due to unavailability, investigation was limited.The information provided states: ¿during an unknown procedure, the 7mm flexible drill broke while beginning to drill the tunnel¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied, surgical techniques, proper care and handling.The instruction for use states: ¿do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no complaints of this failure were found.

• Brand Name: DRILL FLEXIBLE ENDOSCOPIC CANN 7MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9708498
• MDR Text Key: 179347803
• Report Number: 1219602-2020-00215
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 03596010601445
• UDI-Public: 03596010601445
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7209008
• Device Catalogue Number: 7209008
• Device Lot Number: 50517092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1