MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER 5.5 EP-1 DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205325
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during hip arthroscopy procedure, the blade was showing metal debris in the joint when it is used and rubbing on the inside shaft of the blade.It is unknown if there was a delay and how the procedure was completed.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
One 7205325 disposable 5.5mm ep-1 abrader blade used in treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited, but photos showed rotational wear band damage.This is caused by excessive side-loading and is a source of debris.This confirms excess side loading was a factor during attempted use.If further information, becomes available, the complaint may be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.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) blade hand piece not fully loaded and or locked into mdu hand set.5) change of approach during use.Per ifu 1060595: ¿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 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 (ifu) 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
Internal complaint reference (b)(4).The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images showed rotational wear band damage.A visual inspection revealed that the suspected device was free of debris, so there were not visible metal shavings on the blade inner or outer blades.Both heat shrink tubes were present on the inner blade.At the proximal end of the inner blade, the surface finish of the metal appeared to be scratched off and flaking.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 a repeat issue.A review of the part drawing found that the surface roughness was specified.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings: 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).The complaint was confirmed.Potential factors include unintentional side-loading, lack of irrigation, and inadvertent accumulation of excised materials within the device.No containment or corrective actions are recommended at this time.

• Brand Name: ABRADER 5.5 EP-1 DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10423582
• Report Number: 1219602-2020-01267
• Device Sequence Number: 2949031
• Product Code: HAB
• UDI-Device Identifier: 03596010251534
• UDI-Public: 03596010251534
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 04/13/2021

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: 10/08/2024
• Device Model Number: 7205325
• Device Catalogue Number: 7205325
• Device Lot Number: 50832010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 04/09/2021
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/09/2020; 04/13/2021
• 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: Other