MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 8.5MM; BIT, SURGICAL

Model Number	72204043
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during and acl procedure, internal to patient, while trying to ream through tibial bone the retrograde drill mechanism that retracts and opens the retrograde blade broke upon resistance from the hard tibial bone.The procedure was successfully completed with non-significant delay using a s+n back-up device.No further complications were reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an acl procedure, while trying to ream through tibial bone, the retrograde drill mechanism that retracts and opens the retrograde blade broke upon resistance from the hard tibial bone.This occurred with two drills.The procedure was successfully completed with non-significant delay using a s+n back-up device.No further complications were reported.
Additional Manufacturer Narrative
Correction in b5.Quantity of affected devices was two.
Additional Manufacturer Narrative
The reported device was received for evaluation.It was determined the device did not contribute to the reported event.A complaint history review concluded this was a repeat issue.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 review of the customer provided image found the retrograde bit has been partially deployed, and the actuator is bent out of the drill bit window.A visual inspection of the returned device found that it is not in its original packaging.Two devices were returned in the box.Device one is worn from use, and the actuator is bent out of the drill bit window.The actuator is also disconnected from the gray slider.The retrograde bit is not sitting correctly in the drill bit window.There is debris on the device.The markings on this device confirm that it is the 8.5mm drill.Device two is worn from use, and the actuator is bent out of the drill bit window.The actuator is also disconnected from the gray slider.The retrograde bit is not sitting correctly in the drill bit window.There is debris on the device.The markings on this device confirm this device as an 8mm drill.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.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 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.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.
Additional Manufacturer Narrative
H10 h3, h6 the reported device was received for evaluation.It was determined the device did not contribute to the reported event.A complaint history review concluded this was a repeat issue.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 review of the customer provided image found the retrograde bit has been partially deployed, and the actuator is bent out of the drill bit window.A visual inspection of the returned device found that it is not in its original packaging.Two devices were returned in the box.Device one is worn from use, and the actuator is bent out of the drill bit window.The actuator is also disconnected from the gray slider.The retrograde bit is not sitting correctly in the drill bit window.There is debris on the device.The markings on this device confirm that it is the 8.5mm drill.Device two is worn from use, and the actuator is bent out of the drill bit window.The actuator is also disconnected from the gray slider.The retrograde bit is not sitting correctly in the drill bit window.There is debris on the device.The markings on this device confirm this device as an 8mm drill.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.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 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.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 8.5MM
• 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: 13003764
• Report Number: 1219602-2021-02713
• Device Sequence Number: 19912515
• Product Code: GFG
• UDI-Device Identifier: 00885554037722
• UDI-Public: 00885554037722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/18/2022

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: 06/07/2024
• Device Model Number: 72204043
• Device Catalogue Number: 72204043
• Device Lot Number: 4905309
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 05/02/2022; 05/02/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/22/2022; 05/06/2022; 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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: Other
• Patient Sex: Unknown