MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER,4.0,EP-1,DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205324
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a procedure blade broke inside the patient however it is unknown if pieces were retrieved and how.It is unknown how the procedure was completed since no back up was available.No patient injuries or delay reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: one 7205324 disposable 4.0mm ep-1 abrader blade reported on.The product was used for treatment but was not returned for evaluation.This product is sold as a box of 6; not intended to be sold individually.Due to unavailability, evaluation was limited.If further information becomes available, the complaint may be revisited.Instruction for use documentation contains precautionary statements and recommendations for proper use of product.Factors that may affect device performance include: procedure location and tissue condition, device ability and surgical ability.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1) incompatible force or torque or leverage applied.2) insufficient irrigation or engaging the device without suction.3) seizing of blades due to inadequate bio matter excision.4) change of approach during use.Per instruction for use: ¿irreversible damage may occur to blades or burrs if they are run without the flow of irrigation (dry).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).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.¿ complaint history review indicated a similar allegation for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.

• Brand Name: ABRADER,4.0,EP-1,DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9861304
• Report Number: 1219602-2020-00538
• Device Sequence Number: 2533383
• Product Code: HAB
• UDI-Device Identifier: 03596010251527
• UDI-Public: 03596010251527
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 06/01/2024
• Device Model Number: 7205324
• Device Catalogue Number: 7205324
• Device Lot Number: 50779782
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1