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

Catalog Number 72201519

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/18/2019

Event Type  malfunction  

Event 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.

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 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
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8267323
• MDR Text Key: 133832275
• Report Number: 1219602-2019-00100
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010621641
• UDI-Public: 03596010621641
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1