MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	2296-3-125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Upon inspection of the received complaint device bio-material was identified.Inspection of the device found that the keyway was damaged and a portion of the keyway was broken.A broken portion of the of the blade was returned with the device.The broken part of the keyway was not returned.A portion of the blade displayed signs of heavy wear.The depth markings and the catalog number were visible.Inspection of the teeth showed signs of wear and damage.Inspection of the keyway showed signs of heavy wear.A review of the dhr could not be performed as the lot number was not reported.During reprocessing, the blades are inspected and rejected for damage.Therefore, the most likely root causes are: user applied excess pressure to surgical accessory, patient bone harder/more dense than anticipated, device not tightened correctly.The instructions for use (ifu) state: observe surgical accessories for damage that could impair proper operation and replace any damaged accessory immediately.Do not employ bent or damaged surgical accessories in surgery.When using slotted fixture or alignment guides, first insert the blade into the slot.Irrigate blades during use to prevent them from becoming hot from friction.Irrigation is necessary at all times when using blades with alignment guides or slotted cutting fixtures.Do not apply excessive lateral force.Before beginning the procedure, verify overall compatibility of all instruments and accessories to be used during the surgical procedure.Inspect the device for overall condition and physical integrity.Do not use if any damage is noted.Return the device and package to stryker sustainability solutions.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that during a right total knee arthroplasty, a portion of the micro saw blade broke while in use.An x-ray was performed at the end of the case to ensure there were no remaining fragments left in the patient.The piece was located.No further issues reported.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 10892109
• Report Number: 0001056128-2020-00086
• Device Sequence Number: 2799081
• Product Code: GFA
• UDI-Device Identifier: 00885825012519
• UDI-Public: 00885825012519
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2296-3-125
• Device Catalogue Number: 2296-3-125RR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention