MAUDE Adverse Event Report: OSTA SHAVER BLADE, 4MM, 40DEG, ROTATABLE, SERRATED, CLOSED, 5/PK

Model Number SB4040RC

Device Problems Complete Blockage (1094); Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

- reconfirmation of complaint failure: our inspection could not find any external damages or cracks on the blades.-other defect that has been found during investigation: no other findings.-whether the device meet specifications?: it was reported that a piece of device fell off, but it doesn't affect its functionality.Thus the device conforms to the specification.-other investigation result.Sb4040rc is assumed to be the subject device that was actually used during the event, based on the picture provided by the user facility and user's comments.The debris(metal fragment) was not returned to omsc.We could estimate the size of debris about 2mm based on the picture.The relationship of the device to the reported incident or adverse event.(in case of pae): a debris came out from the subject device fell into patient.The pae is associated with the subject device.Conclusion summary: there is no significant external damage or crack on the distal end of the device( both the inner blade and the outer blade.) we suspect that the debris spouted out from the distal end of device is a part of nickel plating on the inner blade.The inner blade seems to have no damage of plating as long as we observed from outside.It may have plating damage inside.The device will be sent to osta for deeper investigation to determine the exact root cause.Comments to customer or originator/sales-bc: when a clog is encountered, please withdraw the blade from nasal cavity before starting declog feature to remove the clog.Please explain your customer to follow the caution note below that is described in the instruction for use."to avoid splashing of potentially hazardous biomaterial, always ensure that the blade tip is fully submerged in sterile water or sterile saline before squeezing the declog pressure bulb.Water or saline in the dish must be deep enough to fully submerge the blade tip and cover the blade window.".

Event Description

The subject blade (sb4040rc)combined with a handpiece (mdhp100a) was used during a tumorectomy by endoscopic sinus surgery.During the first half of the procedure, a burr combined with a handpiece was stopped working.The procedure was continued with reserve handpiece (mdhp100a), burr (bur4015dt), tube set (ts101dc).After completion of the treatment with the burr, the procedure was continued with replaced subject blade (sb4040rc).Tissue was clogged in the blade during the procedure.When the de-clog air bulb was pushed to de-clog the blade, foreign debris estimated to be metal fragments or plating pieces were spouted out from the tip of blade and fallen inside patient¿s body.After retrieving the foreign debris with an uncertain suction tube owned by the hospital, the procedure was completed using a reserve blade (sb4040rc).There is no patient¿s injury reported.The retrieved foreign debris was not returned.This complaint (b)(4) is regarding the blade (sb4040rc) involved with foreign debris falling inside patient¿s body.Another complaint (b)(4) is regarding the first handpiece combined with the burr which was stopped working.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2 and h10.A dhr review was performed and found no abnormalities in documentation or manufacturing process.

Manufacturer Narrative

This supplemental report is being submitted to provide device evaluation from the original equipment manufacturer (oem).Please see the updates in sections: g4, g7, h2, h6 and h10.The customer's complaint of reported metal shavings coming from the blade was unconfirmed.The returned shaver blades were visually and functionally evaluated for damage to the teeth and interior inner blade shaft for evidence of any grinding or damage that would lead to shavings from the blade were blown out during declogging.This evaluation found the only substance that was being blown from the device was residual molykote from the assembly process.

• Brand Name: SHAVER BLADE, 4MM, 40DEG, ROTATABLE, SERRATED, CLOSED, 5/PK
• Manufacturer (Section D): OSTA; 136 turnpike road; southborough MA 01772
• MDR Report Key: 6518420
• MDR Text Key: 73742693
• Report Number: 1037007-2017-00004
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT-EQJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Model Number: SB4040RC
• Device Lot Number: JC931951
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1