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

Model Number	72204046
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a knee procedure and when attempting to flip the trunav drill, the small rod that opens the reamer broke and it was impossible to retrograde ream.The procedure was completed with a backup device and no significant delay or further complications 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 received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned without its complementary components.The internal wire appeared to be disengaged from the grey slider.There was minor wear on the metal from use.A functional evaluation concluded that the grey slider was no longer connected to the rotating cutter and was unable to change its orientation.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.A review of the instructions for use found the following warnings and precautions related to the reported failure: ¿ the cannulated power drill must always be set to forward when drilling tunnels and retrograde-drilling sockets.¿ prior to deploying the cutting blade, ensure that the guide wire is retracted within the groove approximately 1.5 inches (38 mm) within the retrograde drill shaft and is not in the drill head window.The groove in the guide wire provides tactile feedback that it is retracted to the proper position.This will prevent possible device failure.The complaint was confirmed.Factors that could have contributed to the reported event include drilling with an exposed guide wire, excessive force during use, or use of the reverse function when drilling.
Additional Manufacturer Narrative
D3 corrected: manufacturing name, city and address.This report was inadvertently submitted under manufacturer report number ¿(b)(4)correct manufacturer report number is ¿(b)(4).

• 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.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11416213
• Report Number: 1643264-2021-00890
• Device Sequence Number: 17147488
• Product Code: GFG
• UDI-Device Identifier: 00885554037753
• UDI-Public: 00885554037753
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2022

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: 06/19/2024
• Device Model Number: 72204046
• Device Catalogue Number: 72204046
• Device Lot Number: 4899154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/02/2021; 04/06/2022
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/08/2021; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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: Required Intervention
• Patient Sex: Unknown