MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 7.5MM; BIT, SURGICAL

Model Number	72204041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an acl reconstruction, as the acufex trunav retrograde drill, 7.5mm was being used to ream over the 2.4 mm guide wire, the tip of the drill broke off and got stuck in the femoral tunnel.The broken part was retrieved from the patient.The procedure was finished with a backup device and a delay of 10 minutes.No patient complications were reported all available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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.An analysis of the customer provided images revealed that the drill tip had fractured off the device.There was some bending present in the metal proximal to the fracture.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were 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.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device tip, inconsistent drill speed, or reuse of a single use device.

• Brand Name: RETROGRADE DRL 7.5MM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11555715
• Report Number: 1219602-2021-00619
• Device Sequence Number: 17126797
• Product Code: GFG
• UDI-Device Identifier: 00885554037708
• UDI-Public: 00885554037708
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2023
• Device Model Number: 72204041
• Device Catalogue Number: 72204041
• Device Lot Number: 5045355
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention