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

Model Number	UNKNOWN
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).D4, lot no.: the following are the lot numbers reported: 5453131 (1 device) and 5507157 (1 device); however, it is unknown which of the 2 contributed with the delay greater than 30 minutes.D4, exp.Date: expiration dates for each of the 2 lots reported: 13-oct-2025 (5453131), 01-jun-2028 (5507157).H4, mgf.Date: manufacturing dates for each of the 2 lots reported: 13-oct-2022 (5453131), 01-jun-2023 (5507157).
Event or Problem Description
It was reported that during a posterior cruciate ligament reconstruction surgery, when drilling with two retrograde drills, the distal cutting head protruded and stopped working, it was unable to move in or out.The devices were removed through forceful measures.The procedure was completed changing the surgical approach from an all-inside technique to a conventional technique.There was a delay greater than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
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 disconnected from the grey slider.There is biological debris on the returned device.A functional assessment of the device found it is unable to function as designed due to the actuator bar being disconnected from the grey slider.This failure has been determined to be related to the reported event.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.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.No containment or corrective actions are recommended at this time.H11: corrected information d4, model no.: the following are the reported part numbers: 72204043 (1 device) and 72204041 (1 device); however, it is unknown which of the 2 contributed with the delay greater than 30 minutes.

• 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: 19011826
• Report Number: 1219602-2024-00663
• Device Sequence Number: 19803505
• Product Code: GFG
• UDI-Device Identifier: 00885554037722
• UDI-Public: 00885554037722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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 Model Number: UNKNOWN
• Device Catalogue Number: 72204043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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