MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 9.5MM; BIT, SURGICAL

Catalog Number	72204045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tibial retrograde tunnel surgery, the distal end of the 9.5mm retrograde drill bit remained in the tibial tunnel, and the drill bit was recovered from the patient.The procedure was completed with non-significant delay using a s+n back up device.Antibiotic therapy was started and no further complications were reported.
Event or Problem Description
It was reported that during a tibial retrograde tunnel surgery, the distal end of the 9.5mm retrograde drill bit remained in the tibial tunnel, and the drill bit was recovered from the patient.The procedure was completed without surgical delay using a s+n back up device in the originally drilled bone hole.Antibiotic therapy was started, and no further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information: a2, a3, a4, b1, b2, b5.Corrected data: h1, h6: health effect - impact code.
Additional Manufacturer Narrative
H6 (health effect - impact code) updated.H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
Investigation updated: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10: h2: additional information: d4: lot number and exp date.
Additional Manufacturer Narrative
H6 type of investigation codes updated.Investigation updated: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not received for evaluation.A processing error at the courier prevented the product return.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: RETROGRADE DRL 9.5MM
• 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: 18097445
• Report Number: 1219602-2023-02198
• Device Sequence Number: 20799272
• Product Code: GFG
• UDI-Device Identifier: 00885554037746
• UDI-Public: 00885554037746
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 02/27/2026
• Device Catalogue Number: 72204045
• Device Lot Number: 5473324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/18/2023; 01/24/2024; 03/08/2024; 04/02/2024; 07/15/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/26/2023; 01/26/2024; 03/13/2024; 04/09/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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; Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 65 KG