MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOXED INCISOR BLADE 4.5(6BX); SAW, POWERED, AND ACCESSORIES

Catalog Number	7205332
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a rotator cuff repair, the boxed incisor blade broke while cleaning the tissue.The procedure was completed without surgical delay, the device was not used again.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information on: b5 & h6 (impact code).
Event or Problem Description
It was reported that during a rotator cuff repair, the boxed incisor blade broke while cleaning the tissue.The procedure was completed without surgical delay, the device was not used again, no pieces fell into the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with original packaging.The color scheme of the device matches the print.The distal end of the inner blade is broken off and stuck inside the outer blade.The distal metal edges of the inner blade, where the end is missing, are shredded and curled from the rotational force.There is heavy scoring on the proximal end of the inner blade.The teeth on the inner and outer blades are worn down from heavy use.Bio debris is present.A functional evaluation cannot be performed due to the broken inner blade.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 definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences.Other factors include an application of excessive force to the device or excessive side loading.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.Internal complaint reference: (b)(4).B5 and h6: event description and codes updated.
Event or Problem Description
It was reported that during a rotator cuff repair, the boxed incisor blade broke while cleaning the tissue.The procedure was completed without surgical delay, the device was not used again.No further complications were reported.Patient is stable.

• Brand Name: BOXED INCISOR BLADE 4.5(6BX)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• 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: 20805703
• Report Number: 1219602-2024-02646
• Device Sequence Number: 13245571
• Product Code: HAB
• UDI-Device Identifier: 03596010251602
• UDI-Public: 3596010251602
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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 Catalogue Number: 7205332
• Device Lot Number: 51152400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 01/10/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 12/20/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 67 YR
• Patient Sex: Female