MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 31.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2296003125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
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 surgery, the blade broke.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 bend present in the blade suggests that it was subjected to an excessive bending force.This bending force is the most likely cause of the mount break.The bending forces could have occurred by pushing the handpiece forward or pulling it backwards or twisting the handpiece while the end of the blade was constrained.The bent teeth and indentations to the sides of the blade and outermost teeth suggest that the blade made contact with metal, such as cut guides or surgical instruments, while the blade was in operation.Shock loading caused by metal contact could have also caused / contributed to the mount break.The instructions for use(ifu) of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the blade and cause tissue damage and/or loss of tactile control." the associated devices ifu's state that the device and associated handpieces are "intended for surgical procedures involving cutting bone and hard tissue".
Event or Problem Description
It was reported that during surgery, the blade broke.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: PRECISION THIN (9.0 X 0.38 X 31.0MM)
• 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: 10233499
• Report Number: 0001811755-2020-01632
• Device Sequence Number: 3093074
• Product Code: GFA
• UDI-Device Identifier: 04546540046529
• UDI-Public: 04546540046529
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: 03/01/2025
• Device Model Number: 2296003125
• Device Catalogue Number: 2296003125
• Device Lot Number: 20090017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1