MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL 4.5MM DSPL. EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205306
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during procedure the full radius blade shaver piece broke inside the patient's knee.No delay and a back up was available to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h6.One 7205306 disposable 4.5mm full radius elite product used for treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.If additional information becomes available, the complaint can be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Per instructions for use: ¿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.Make sure the hand piece is off while changing blade tip position.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Irreversible damage to blades or burrs will result if they are run without the flow of irrigation (dry).¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with original packaging and the device has debris on it, the device shaft has sheared off in to two pieces.No other physical damage is visible to the device.A functional evaluation of the returned device found that device is in two pieces therefore no function test can 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate a review of the inspection process found that each component should be visually inspected for all non-conforming attributes defined in the procedure.It was determined the device did not contribute to the reported event.This case reports a breakage of the full radius blade shaver, it is unknown if the broken piece was retrieved from the patient.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Conclusion: based on the limited information provided, the root cause of the reported breakage could not be determined.The material of the device is 304 stainless steel which is an austenitic stainless steel alloy intended for surgical applications and is biologically compatible; however, this device is not approved for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the possible retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.The complaint was confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.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.

• Brand Name: FULL RADIUS BL 4.5MM DSPL. EP-1
• 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: 10423602
• Report Number: 1219602-2020-01270
• Device Sequence Number: 2949034
• Product Code: HAB
• UDI-Device Identifier: 03596010251343
• UDI-Public: 03596010251343
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2022

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: 11/18/2024
• Device Model Number: 7205306
• Device Catalogue Number: 7205306
• Device Lot Number: 50840494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/27/2020; 04/14/2022
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/03/2020; 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown