MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 10MM; BIT, SURGICAL

Catalog Number	72204046
Medical Device Problem Codes	Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, the retrograde drill was introduced to make the tunnel, it was evident that the motor was rotating, but the tip of the drill bit did not, after being inspected, it was noted that the drill bit was damaged.Surgery was completed with a back-up device instead.There was a delay greater than 30 minutes and no further complications were reported.Patient's status is stable.
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.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.
Event or Problem Description
It was reported that, during an arthroscopy, the retrograde drill was introduced to make the tunnel, it was evident that the motor was rotating, but the tip of the drill bit did not; both cortices were crossed and when doing the retrograde part, the blade came out and the implant made a sound.The blade was removed to check and it was evident that the blade came loose.Surgery was completed with a back-up device instead.There was a delay greater than 30 minutes and no further complications were reported.Patient's status is stable.
Additional Manufacturer Narrative
H2: additional information b5 h11: h2: corrected information h6: medical device problem code.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The actuator wire is broken into several pieces, none of which are attached to the grey slider.The drills at the distal end of the shaft are fractured off the shaft.A functional assessment of the device found it is not functional due to being broken into several discrete pieces.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the provided videos were reviewed; however, they do not indicate a cause of the reported event.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device or an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: RETROGRADE DRL 10MM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18858356
• Report Number: 1219602-2024-00415
• Device Sequence Number: 3313986
• Product Code: GFG
• UDI-Device Identifier: 00885554037753
• UDI-Public: 00885554037753
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/29/2024

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 Expiration Date: 04/02/2025
• Device Catalogue Number: 72204046
• Device Lot Number: 5007397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 06/06/2024; 07/26/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/03/2024; 06/19/2024; 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 92 KG