MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HOOK PROBE 2.2MM; ACCESSORIES,ARTHROSCOPIC

Model Number 3312

Device Problem Sharp Edges (4013)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2020

Event Type  malfunction  

Event Description

It was reported that the wrist probes were extremely sharp.The performing surgeon believes they are a liability to the wrist arthroscopy procedures they perform, as they can cut into and damage non-targeted tissue during their use.There was a delay greater than 30 minutes in the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: one 2.2mm probe hooks intended for use in treatment was not returned.Per instructions for use: care should be taken to store instrument in a sterilization container in which it will not incur damage from handling or other instruments.Factors that may affect device performance include entanglement with other instruments or devices during sterilization causing dings or burrs.Unapproved refurbishment of instruments.Complaint history review indicated no similar allegations for the lot number reported aside from these related two.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.No further investigation is warranted at this time.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.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 visual inspection of the returned device found that it was not in its original packaging.The laser markings on the device confirm the product identification information.The device is worn from use, and there are abrasions over the surface of the probe.The abrasions on the distal end of the hook probe have created a rough surface.The complaint was confirmed.Factors that could have contributed to the reported event include wear due to continued use of the device over time, rough sterilization processes, or excessive force during 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.No containment or corrective actions are recommended at this time.

• Brand Name: HOOK PROBE 2.2MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10190366
• MDR Text Key: 196285761
• Report Number: 1219602-2020-00954
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010115577
• UDI-Public: 03596010115577
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

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: 3312
• Device Catalogue Number: 3312
• Device Lot Number: 50835710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 11/01/2021
• Supplement Dates FDA Received: 07/22/2020; 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1