MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RETROGRADE DRL 7.5MM; BIT, SURGICAL

Catalog Number 72204041

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that when the retrograde drill 7.5 mm was opened, it was noticed that the wires were not packaged inside the box, the wires were coming out of the sterile packaging.No case was reported; therefore, there was no patient involvement.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual inspection of the returned device found that the device was returned without the inner tray cover and tyvek lid.The inner tray was in the outer tray with the tails of the guidewire outside the confines of both the inner and outer tray.There is continuous residue around the perimeter of the outer tray where the tyvek lid was secured to the outer tray.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 no 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.A review of the device drawings found that the guidewire must be placed in the central slot of the inner tray.The complaint was not confirmed, and the root cause could not be determined.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.No containment or corrective actions are recommended at this time.

• Brand Name: RETROGRADE DRL 7.5MM
• 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: 18267455
• MDR Text Key: 329734603
• Report Number: 1219602-2023-02348
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72204041
• Device Lot Number: 4954642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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