MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRIVER CANNULATED 2MM; SCREW, FIXATION, BONE

Model Number	7207193
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an acl procedure, the tip of the driver snapped off when inserting a rci screw.Backup device was available to complete the procedure.No significant delay and no patient complications were reported.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.A review of the customer provided image found the device with the distal tip fractured from the device.The shaft of the device has debris.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: DRIVER CANNULATED 2MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12456313
• Report Number: 1219602-2021-01824
• Device Sequence Number: 1194609
• Product Code: HWC
• UDI-Device Identifier: 03596010253491
• UDI-Public: 03596010253491
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K921481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 7207193
• Device Catalogue Number: 7207193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1