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

Model Number 7205325

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  Injury  

Event Description

It was reported that during the procedure, the blade was showing metal debris in the joint when it is used and rubbing on the inside shaft of the blade; the procedure was successfully completed with less than 30 minutes delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already captured under (1219602-2020-01266) therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

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.Relationship between the event and device was unconfirmed.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: incompatible force or torque or leverage applied.Insufficient irrigation or engaging the device without suction.Seizing of blades due to inadequate bio matter excision.Blade hand piece not fully loaded and or locked into mdu hand set.Change of approach during use.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 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.Per mi: this case reports metal debris in the joint following the use of the device, it is unknown if the metal debris was removed 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 for the metal debris could not be determined.The material of the inner tube is 304l stainless steel which is an austenitic stainless steel alloy intended for surgical applications and is biologically compatible; however, the metal debris from this device is not approved for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the possible retained metal debris cannot be determined.No further medical assessment can be rendered at this time.Approved by justin templeton, md 10-19-2020 reviewed during mimb on 08-20-2020.A medical investigation will be performed.Proceed based on information provided or available for the investigation; if no relevant clinical information is provided, recommend closure.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event was already captured under (1219602-2020-01266) therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: ABRADER 5.5 EP-1 DSPL BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10445601
• MDR Text Key: 204169337
• Report Number: 1219602-2020-01304
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251534
• UDI-Public: 03596010251534
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7205325
• Device Catalogue Number: 7205325
• Device Lot Number: 50832010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention