MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCPC CANN.DRL.BIT 4.5 STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	7207315
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during an acl knee arthroscopy and meniscus repair, the specialist decided to perform a suspension method using the ultrabutton fixation device.When trying to drill the tunnel using the endoscopic cannulated drill bit of suspension, the drill bit did not go through; since it collided with the guide.The drill bit got damaged in the process; therefore, the tunnel to insert the ultrabutton fixation device couldn't be prepared.The specialist removed the guide and noticed it was bent.It was recommended to change to another drill bit in order to drill the tunnel, but the specialist decided to perform another technique using the biosure regenesorb interference screw.The procedure was completed with a delay greater than 30 minutes.No further complications were reported.The patient status is stable.
Additional Manufacturer Narrative
H10 h6: the shipping information was provided; however, the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: ENDOSCPC CANN.DRL.BIT 4.5 STRL
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 16390606
• Report Number: 1219602-2023-00185
• Device Sequence Number: 5618349
• Product Code: HWE
• UDI-Device Identifier: 03596010425409
• UDI-Public: 03596010425409
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Model Number: 7207315
• Device Catalogue Number: 7207315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male