MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM SYNOVATOR PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Model Number 72203523

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an arthroscopy procedure, there was rust on the tip of the synovator platinum blade.No significant delay and procedure was completed with a backup device with no further complications.

Event Description

It was reported that, during a knee arthroscopy procedure, there was rust on the tip of the synovator platinum blade.The procedure was completed with a backup device with no further complications.A delay equal to or less than 30 minutes was reported.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of the part drawing found that the part must be micro-polished, laser marked, and must be clean.A visual inspection of the returned device found that it was returned outside if its original packaging.There is debris in the blade and on both the outer and inner blade assembly.There is discoloration that resembles rust in the laser etching at the distal tip of the outer blade assembly.The complaint was confirmed and the root cause was associated with manufacturing.Factors that could have contributed to the reported event include improper storage or transport conditions or issues during the plating or passivation process.A complaint notification has been issued to manufacturing management to mitigate future recurrences.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat event.A review of device records showed there were no indications to suggest any manufacturing issues upon release for distribution that would have contributed to the reported event.A review of the part drawing found that the part must be electropolished, laser marked, and must be clean.A visual inspection of the returned device found that it was returned outside if its original packaging.There is debris in the blade and on both the outer and inner blade assembly, indicating it was used.There is discoloration that resembles rust in the laser etching at the distal tip of the outer blade assembly.A review of the results of the presumptive blood test kit confirmed that the substance on the shaft of the device is not blood.A review of the instructions for use found the device is single use and shipped sterile.The document states, ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.¿ the reported event was found after the device was outside of the sterile state and during use.The was no evidence to document the as found condition by the customer.Factors that could have contributed to the investigation findings include moisture on the device from use leading to corrosion during return of the device for complaint investigation.The complaint was confirmed, but the root cause could not be determined due to the state the device was returned in.No containment or corrective actions are recommended at this time.H6: updated codes.

• Brand Name: 4.5MM SYNOVATOR PLATINUM SERIES
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11989120
• MDR Text Key: 255965889
• Report Number: 1643264-2021-02107
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554027839
• UDI-Public: 00885554027839
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203523
• Device Catalogue Number: 72203523
• Device Lot Number: 50919865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female