MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 25.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number 2296003111

Device Problems Material Discolored (1170); Contamination of Device Ingredient or Reagent (2901)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation results.

Event Description

It was reported that there was a potential sterility breach in the packaging of the device.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

Event Description

It was reported that there was a potential sterility breach in the packaging of the device.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

The reported event, for rust/corrosion/tarnishing, was not confirmed based on the reported event that the blade was not used.On inspection of the returned blade the blade showed signs of being used.The blade was evaluated by product engineering who concluded that evidence such as the loading marks present on the top of the blade, material deposited between the teeth of the blade and the bend in the blade itself indicate that this complaint blade was operated in a handpiece and used to cut material.A review of the handpieces for use instructions for use(ifu) for use with this blade contains the following warning; "upon initial receipt and before each use, inspect each component for damage.Do not use any equipment if damage is apparent or the inspection criteria are not met.".

• Brand Name: PRECISION THIN (9.0 X 0.38 X 25.0MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9203665
• MDR Text Key: 162840503
• Report Number: 0001811755-2019-03246
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540046499
• UDI-Public: 04546540046499
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 2296003111
• Device Lot Number: 18198017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1