MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; STAPLE, FIXATION, BONE

Catalog Number 72203160

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/15/2020

Event Type  Injury  

Event Description

It was reported that during an arthroscopy the twist drill flex broke inside the patient, when it was removed the distal tip was gone and flexible portion was frayed.The anchor was inserted with no issue.The procedure was completed without a significant delay using a back-up device.No 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

The reported flexible twist drill for 2.3 anchors, used in treatment, has been returned for evaluation.Visual assessment of the device confirmed the breakage.The drill head has broken free from the flexible cable link.The cable link is bent and slightly uncoiled at the break area.Drill head was not returned.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the drill.Operating the drill in a counter clock-wise rotation.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TWIST DRILL FLEX CRVD FOR 2.3 SA
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10031328
• MDR Text Key: 190100425
• Report Number: 1219602-2020-00746
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010656018
• UDI-Public: 3596010656018
• Combination Product (y/n): N
• PMA/PMN Number: K102660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Catalogue Number: 72203160
• Device Lot Number: 2021365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention