MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203160

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/22/2020

Event Type  malfunction  

Event Description

It was reported that during latarjet surgery, the surgeon inserts the drill and starts drilling, it makes two turns and then makes a "crack" sound, seems like the drill tip got blocked in the bone while drilling and the whole drill shaft got twisted and broke at 2mm above the cortical bone, with the distal tip still in the patient's bone.The surgeon tries around 30 min to remove it, unsuccessfully.He decides to keep on with the surgery and come back to it later to try to remove it.He fixes his posterior labrum, performs his latarjet and when done he comes back to try to remove the distal tip still within the bone, it takes 1.30 additional hours for the surgeon to find a way to remove the drill tip, could not take it out by pulling on it, so the surgeon had to remove some cortical bone around, and then push it forward in an oblique way.He finally manages to remove the tip.The surgeon used another portal (more superior) for fixation as he did not want to reuse a flexible drill bit on this patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned with significant wear.The drill tip had fractured.There was deformation at the distal tip, the point of breakage, and on the flexible rod.There were scratches in the metal along the main rod.There was no debris.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.Adequate supporting clinical documentation to fully evaluate the root cause of the event was not received.Although the case reports an extended surgical time, the patient status was reported as ¿good¿ following the procedure.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: TWIST DRILL FLEX CRVD FOR 2.3 SA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10836324
• MDR Text Key: 216127956
• Report Number: 1219602-2020-01839
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010656018
• UDI-Public: 03596010656018
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: 72203160
• Device Catalogue Number: 72203160
• Device Lot Number: 50634824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention