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

Model Number	6425127105
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not available for return.
Event or Problem Description
It was reported that during preparation for a surgical procedure, a residue was noted on the blade.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 quality investigation is complete.H3 other text : device discarded by customer.
Event or Problem Description
It was reported that during preparation for a surgical procedure, a residue was noted on the blade.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: 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-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 12042257
• Report Number: 3015967359-2021-01215
• Device Sequence Number: 4110937
• Product Code: HWE
• UDI-Device Identifier: 07613327143744
• UDI-Public: 07613327143744
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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 Model Number: 6425127105
• Device Catalogue Number: 6425127105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1