MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL GDE SPIKED TIP 6X3.5; ACCESSORIES,ARTHROSCOPIC

Model Number 7209500

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Event Description

It was reported that, the newly purchased "drill guide spiked tip (6x3.5)" was rusty.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3.H6: the reported device was received for evaluation.There was a relationship found between the device and 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The device has discoloration around the hub on the proximal end of the device.An assessment of the customer provided images shows the complaint device, with the discoloration around the hub as well as another device with discoloration near the distal tip.The complaint was confirmed, and the root cause could not be determined.Factors that may have contributed to the reported event include material degradation from repeated sterilization or improper cleaning techniques.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: DRILL GDE SPIKED TIP 6X3.5
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 10788040
• MDR Text Key: 214654205
• Report Number: 1219602-2020-01769
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010474599
• UDI-Public: 03596010474599
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 7209500
• Device Catalogue Number: 7209500
• Device Lot Number: 50818975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/23/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1