MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 10.5MM; BIT, SURGICAL

Model Number	72204047
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy procedure, a total of two (2) 10.5mm trunav retrograde drill devices easily broke when handle.The procedure was successfully completed with non-significant delay using a back-up device.No further complications were reported.
Event or Problem Description
It was reported that during a knee arthroscopy procedure, a total of two (2) 10.5mm trunav retrograde drill devices easily broke when handled.The procedure was successfully completed with non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H2: additional information ¿b5¿.H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned devices found that it is not in their original packaging.Device 1 the retrograde bit and the actuator wire are no longer attached to the drill shaft and were not returned.Device 2 the retrograde bit is fractured away from the actuator wire and was not returned.The actuator wire is still attached to the grey slider and is deformed at the distal end.Both devices have debris on them.This case reports, that during a knee arthroscopy procedure, a total of two 10.5mm trunav retrograde drill devices easily broke when handle.The devices did not break inside the patient.The procedure was successfully completed with non-significant delay using a back-up device.The patient¿s status was reported as ok.Should additional information be provided, the investigation will be reopened.The complaint was confirmed, and the root cause was associated with unintended use of the device.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 inconsistent with normal use.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.

• Brand Name: RETROGRADE DRL 10.5MM
• 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: 15254299
• Report Number: 1219602-2022-01191
• Device Sequence Number: 5905800
• Product Code: GFG
• UDI-Device Identifier: 00885554037760
• UDI-Public: 00885554037760
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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: 01/14/2025
• Device Model Number: 72204047
• Device Catalogue Number: 72204047
• Device Lot Number: 4954699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown