MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ABRADER, 3.5, MAG-MINI, DISP. BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201519
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure for resection of bone spurs, the tip of the blade were came out.The piece was removed.No patient injuries and complications were reported.
Additional Manufacturer Narrative
One (b)(4) mini mag 3.5mm blade returned.The complaint stated: ¿the tip of the blade came out.¿ the entire product was returned for evaluation.No original packaging was present except a product label.There is evidence of a previous weld where there is discoloration generated from the process.There is a fractured bead at the tube edge, therefore the blade bulb is now able to be separated from the mating blade tube.On the inner blade, the proximal protective sleeve has migrated forward out of position specified by the drawing.(the spec is for the sleeve¿s front edge to be 2.490¿ from the blade bulb end.The edge is @ 1.40¿.) rotational scratches; skiving, was found on the surface of the inner blade.There is grit from skiving adhered to the blade edges.Symptoms indicate that force was a factor for the damages attained.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.No root cause related to the manufacture of this device was confirmed.Correction.
Event or Problem Description
It was reported that during the procedure for resection of bone spurs, the tip of the blade came out.The piece was removed from patient.There was no backup device to complete the procedure.No patient injuries were reported.

• Brand Name: ABRADER, 3.5, MAG-MINI, DISP. BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8267323
• Report Number: 1219602-2019-00100
• Device Sequence Number: 1699106
• Product Code: HAB
• UDI-Device Identifier: 03596010621641
• UDI-Public: 03596010621641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/25/2019

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: 08/12/2021
• Device Catalogue Number: 72201519
• Device Lot Number: 50752582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1