MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 11MM; BIT, SURGICAL

Catalog Number	72204048
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: case (b)(4).
Event or Problem Description
It was reported that during a meniscus transplantation, the procedure started with the 2.4mm guide to make the first tibial tunnel, the initiator was left fixed in the tunnel, the drill was removed to place the retrograde drill bit, the second drilling was made, the first initiator bit of the drill was removed until it stopped and proceeded to deploy the blade, but it did not deploy because it was found loose in the button part of the retrograde drill.The broken piece was removed from patient.The procedure was completed with a delay of 5 minutes using a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The retrograde drill was returned with the actuator bar disengaged from the grey slider.There is biological debris on the returned items.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force during use, failure to retract the guidewire far enough back before attempting to deploy the blade, using the reverse function while drilling, attempting to deploy the blade while still inside the bone tunnel, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 11MM
• 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: 18563253
• Report Number: 1219602-2024-00147
• Device Sequence Number: 6660820
• Product Code: GFG
• UDI-Device Identifier: 00885554037777
• UDI-Public: 00885554037777
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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
• Report Date (Section B): 02/29/2024

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: 01/31/2025
• Device Catalogue Number: 72204048
• Device Lot Number: 4954717
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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 Sex: Unknown