MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 11MM; BIT, SURGICAL

Model Number	72204048
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the end of the retrograde drill was broken.It is unknown when the event happened relative to surgery.A backup device was available to complete the procedure.There was no surgical delay, and no further complications were reported.
Event or Problem Description
It was reported that the end of the retrograde drill was broken.It is unknown when the event happened relative to the knee ligamentoplasty procedure.A backup device was available to complete the procedure.There was no surgical delay, and no further complications were reported.
Additional Manufacturer Narrative
Additional information in a2, a3 and a4.B5 was updated.H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned device found that it is not in its original packaging.The retrograde bit is fractured at the distal end across from the actuator wire connection.The actuator wire is connected to the grey slider and the actuator wire is connected to the fractured retrograde drill.There is debris on the device.A functional assessment of the device found the retrograde bit is unable to deploy correctly due to the fracture at the distal end across from the actuator wire connection.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 an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, 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.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.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.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 11MM
• 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: 14911685
• Report Number: 1219602-2022-00945
• Device Sequence Number: 2031638
• Product Code: GFG
• UDI-Device Identifier: 00885554037777
• UDI-Public: 00885554037777
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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 Expiration Date: 09/23/2024
• Device Model Number: 72204048
• Device Catalogue Number: 72204048
• Device Lot Number: 4937127
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 73 KG