MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM INCISOR PLUS PLAT BLD; SAW, POWERED, AND ACCESSORIES

Catalog Number	72205106
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during set up for a knee arthroscopy, the package of the incisor plus plat blade was broken.There was a back-up device available and a surgical delay of less than 30 minutes was reported.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.One corner of the plastic molding is broken off.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 review of device assembly found that appearance: parts are to be free of blowouts and burn marks, incomplete forming, smudges, grease & oil spots, nicks, burrs spikes or ragged edges, cuts, tears or cracks.The root cause was associated with a transport or storage failure.Factors that could have contributed to the reported event include rough handling during transport or storage, or exposure of the packaging to excessive heat.No containment or corrective actions are recommended at this time.

• Brand Name: 3.5MM INCISOR PLUS PLAT BLD
• 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: 18543648
• Report Number: 1219602-2024-00141
• Device Sequence Number: 9081006
• Product Code: HAB
• UDI-Device Identifier: 00885556708873
• UDI-Public: 00885556708873
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 72205106
• Device Lot Number: 51103611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2023
• 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: Unknown