MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6425127105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during preparation for a surgical procedure, it was noted that the tip of 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.
Event or Problem Description
It was reported that during preparation for a surgical procedure, it was noted that the tip of 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.Update; it was subsequently reported that during a surgical procedure, it was noted that the tip of 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
The reported blade reported involved with this event was returned for evaluation and the reported failure of blade breakage was confirmed.The device was sent to the product engineering group who concluded that the observed damage to the blade teeth is consistent with metal contact while cutting.It is possible that excessive force and/or the application of a bending moment along with metal contact while cutting could have caused the blade to break.The handpieces for use with this blade instructions for use(ifu) contain the following indications for use "the stryker precision system is intended for use in the cutting and shaping of bone and other bone related tissue.The intended surgical applications are orthopedic surgeries involving the shoulder, hip, knee, and ankle." the instructions for use(ifu) also contain the following warning; "do not apply excessive pressure, such as bending or prying, with the cartridge.Excessive pressure may bend or fracture the cartridge and result in tissue damage, loss of tactile control, and/or the ejection of cartridge fragments at a high velocity.".

• Brand Name: STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM)
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8529500
• Report Number: 0001811755-2019-01231
• Device Sequence Number: 1899883
• Product Code: HWE
• UDI-Device Identifier: 07613327143744
• UDI-Public: 07613327143744
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: 10/01/2023
• Device Catalogue Number: 6425127105
• Device Lot Number: 18284017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1