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

Model Number	72203521
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy, the full radius platinum series blade was leaving a black residue on the femoral condyle that looked like metal debris and was not possible to be removed.The procedure was successfully completed with non-significant delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: 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 complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 review of risk management files found that the reported failure was documented appropriately.An analysis of the customer provided image showed that in the unclear portion of the image there is some discoloration, but it can¿t be determined as to what caused the discoloration.It was reported the full radius platinum series blade was leaving a black residue on the femoral condyle that looked like metal debris that was fine and impossible to be removed.The root cause of the reported issue could not be determined based on the limited clinical information provided.However, we cannot rule out a procedural variance as the likely case of the reported failure.The instructions for use does caution that ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.¿ for s&n instruments, the material is approved for short-term contact; however, no data for long-term exposure is available as the instrument is manufactured and intended as an externally communicating device, not intended for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the possible retained metal debris cannot be determined.It was reported the procedure completed with a non-significant delay or patient harm.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.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.

• Brand Name: 4.5MM FULL RADIUS PLATINUM SERIES
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12550764
• Report Number: 1219602-2021-02169
• Device Sequence Number: 14283564
• Product Code: HAB
• UDI-Device Identifier: 00885554024333
• UDI-Public: 00885554024333
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2026
• Device Model Number: 72203521
• Device Catalogue Number: 72203521
• Device Lot Number: 50920994
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention