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

Catalog Number 72204045

Device Problems Break (1069); Material Deformation (2976); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Event Description

It was reported that during a knee arthroscopy, the acufex retrograde drill's blade was not working correctly, no more details are available.No additional patient information is available.The procedure was successfully completed with a non-significant surgical delay using a smith and nephew back up device.No further complications were reported.The results of investigation revealed that the device´s outer shaft with depth markings was fractured away from the inner shaft and the distal end was deformed and totally crimped out; as well the actuator wire was attached to the grey slider, however the entire distal end is missing and it has biological debris.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

H6, medical device problem code updated.H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device has the outer shaft with depth markings fractured away from the inner shaft.The actuator wire is attached to the grey slider but the entire distal end of the device is missing.The distal end of the outer shaft is deformed and completely crimped shut.There is biological debris on the returned device.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 has been 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, an impact event inconsistent with normal use, misuse or rough handling.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 9.5MM
• Type of Device: 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: 18276023
• MDR Text Key: 329848473
• Report Number: 1219602-2023-02375
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1