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

Model Number	3312
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).
Event or Problem Description
It was reported that during a small joint arthroscopy, internal to the patient, the hook probe has a sharper cut at the hook than before.The procedure was completed without significant delay with a different surgical technique.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images revealed that the probes shown appeared to be more rectangular and less polished than the standard probes.The ends of the devices appeared to have sharp edges.A visual inspection revealed that four devices were returned in similar condition.The tips of the probes were sharp and appeared to be unfinished.The edges were not smooth.The laser markings were clear and there was minimal wear on the devices.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the drawing found that the sharp edges at the tip must be broken.The tip is also specified to have been blasted with glass beads to break sharp edges.It must have a smooth transition throughout the radius.The complaint was confirmed, and the root cause was associated with manufacturing.A complaint notification was issued to manufacturing management to mitigate future occurrences.Internal complaint reference: (b)(4).

• Brand Name: HOOK PROBE 2.2MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11334446
• Report Number: 1219602-2021-00334
• Device Sequence Number: 823919
• Product Code: NBH
• UDI-Device Identifier: 03596010115577
• UDI-Public: 03596010115577
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3312
• Device Catalogue Number: 3312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention