MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS 5.5MM EP-1 DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205459
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a rotator cuff repair, metal shards from the incisor plus blade were found in patient's shoulder.The procedure was completed with non-significant delay using a back-up device.No further complications were reported.
Event or Problem Description
It was reported that during a rotator cuff repair, metal shards from the incisor plus blade were found in patient's shoulder.Suction was used to remove the metal shards, minor shards were left behind.The procedure was completed with non-significant delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
B5 was updated.H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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 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 clinical review states that the definitive clinical root cause of the reported adverse event could not be determined.These devices are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.Consequently, we cannot make conclusions on the impact of the non-implantable foreign body.Although, we cannot rule out the possible corrosion, micro-motion/migration, local skin irritation/discomfort from the minor shards retained inside of the patient.The future impact to the patient is unknown, but regular follow-up/monitoring would be anticipated.Please refer to the instructions for use for precautions and warnings related to the use of the device.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.
Additional Manufacturer Narrative
H6 codes were corrected (clinical code & impact code).

• Brand Name: INCISOR PLUS 5.5MM EP-1 DSPL BLADE
• 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: 17818827
• Report Number: 1219602-2023-01869
• Device Sequence Number: 15004089
• Product Code: HAB
• UDI-Device Identifier: 03596010252234
• UDI-Public: 03596010252234
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/18/2023

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 Catalogue Number: 7205459
• Device Lot Number: 51118881
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 12/18/2023; 12/18/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/18/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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 Age: 55 YR
• Patient Sex: Male