MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DUAL CUT (19.5 X 0.51 X 50.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	5400003254S1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
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 at the mount.It was also reported there were 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 this damage could have been caused by the blade coming into contact with metal while cutting and/or also under the application of a bending moment while in use.The instruction for use(ifu) of handpieces associated with this blade 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 at the mount.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: MICRO DUAL CUT (19.5 X 0.51 X 50.0MM)
• 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: 10541543
• Report Number: 0001811755-2020-02396
• Device Sequence Number: 304762
• Product Code: GFA
• UDI-Device Identifier: 07613154499830
• UDI-Public: 07613154499830
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 10/27/2020

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: 05/01/2024
• Device Model Number: 5400003254S1
• Device Catalogue Number: 5400003254S1
• Device Lot Number: 19147037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1