MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYNOVATOR EP-1 4.5 ORBIT DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205321
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that when unpacking the synovator blade, it was found to have contamination on the tip.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
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.The customer provided images confirmed the packaging was contaminated.A review of the device history 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 an isolated event.A review of the packaging process summary revealed a visual inspection for particulate and seal for breaches is conducted on a sampling plan.The complaint was confirmed and the root cause has been associated with a manufacturing error.Although every effort is made to control particulate in the controlled clean room, it is not possible to completely eliminate foreign matter in the area due to the human element.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.
Additional Manufacturer Narrative
Manufacturer complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in an original blister tray with the batch number of the complaint on the lidstock.The color scheme matches the print.The outer blade shows no discrepancy.The inner blade tip has an orange/burnt color from the lubricant coat during manufacturing and some oxidation.A functional evaluation using a reference control system showed the device ran in all modes as intended.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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include contact with foreign substances after opening the package.No containment or corrective actions are recommended at this time.

• Brand Name: SYNOVATOR EP-1 4.5 ORBIT 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: 10972971
• Report Number: 1219602-2020-02011
• Device Sequence Number: 4214522
• Product Code: HAB
• UDI-Device Identifier: 03596010251497
• UDI-Public: 03596010251497
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2023

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 Expiration Date: 01/30/2025
• Device Model Number: 7205321
• Device Catalogue Number: 7205321
• Device Lot Number: 50854343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/15/2021; 10/25/2023
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/20/2021; 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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