MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.19X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	6125119090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade sounded unusually loud and on inspection, the saw blade where it attaches to the handpiece was broken.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the reported event, for blade breakge, was not confirmed as the blade was not returned for evaluation.Without the blade, the root cause cannot be determined.H3 other text : device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade sounded unusually loud and on inspection, the saw blade where it attaches to the handpiece was broken.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the reported blade involved with this event was returned for evaluation and the reported failure of blade breakage was confirmed.The blade was evaluated by product engineering who concluded that the wear to the teeth and indentations along the side of the blade would suggest that the blade did come into contact with metal while cutting.The sudden impact of the blade coming into contact with cut guides/ surgical instruments could have caused the mount tab to fracture at the mount.The bend present in the blade is evidence of deformation due to an excessive force / torque applied to the blade.This excessive force could have caused the mounts to fracture.The instruction for use(ifu) for handpieces for use with this blade contain the following warning; "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and result in tissue damage, loss of tactile control, and/or the ejection of blade fragments at a high velocity".The associated devices ifu's state that the device and associated handpieces are "intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures.".
Event or Problem Description
It was reported that during a surgical procedure, it was noted that the blade sounded unusually loud and on inspection, the saw blade where it attaches to the handpiece was broken.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (25.0X1.19X90MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10332416
• Report Number: 0001811755-2020-01995
• Device Sequence Number: 1045206
• Product Code: GFA
• UDI-Device Identifier: 04546540501509
• UDI-Public: 04546540501509
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup,Followup
• Report Date (Section B): 11/04/2020

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: 11/01/2024
• Device Model Number: 6125119090
• Device Catalogue Number: 6125119090
• Device Lot Number: 19329017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 09/11/2020; 11/04/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/11/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1