MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE 4.5 DSPL EP-1(BX6); SAW, POWERED, AND ACCESSORIES

Model Number	7205313
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the incisors blades were damaged.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The reported device, intended for use 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 confirmed the part and batch numbers.The images indicated shipping damage that compromised the sterile barrier of the devices by cracking the outer plastic.A visual inspection revealed that six devices of the same batch number were returned in the original packaging and box.Four of the devices had damaged packaging in the form of fractures on the hard plastic of the sterile barrier.The creases present on the box and consistent placement of the cracks in the plastic indicated that the box had suffered an impact event or rough handling.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.The complaint was confirmed and the root cause was associated with transport or storage.Factors that could have contributed to the reported event include rough shipping and handling or an impact event during transportation or at the customer site.No containment or corrective actions are recommended at this time.

• Brand Name: INCISOR BLADE 4.5 DSPL EP-1(BX6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11228713
• Report Number: 1219602-2021-00203
• Device Sequence Number: 3805275
• Product Code: HAB
• UDI-Device Identifier: 03596010251411
• UDI-Public: 03596010251411
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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 Expiration Date: 07/07/2025
• Device Model Number: 7205313
• Device Catalogue Number: 7205313
• Device Lot Number: 50882799
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1