MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	6425127105
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that prior to a surgical procedure, it was noted that the seal on the packaging of the device was open.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Event or Problem Description
It was reported that prior to a surgical procedure, it was noted that the seal on the packaging of the device was open.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM)
• 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: 10265236
• Report Number: 0001811755-2020-01706
• Device Sequence Number: 11000583
• Product Code: GFA
• UDI-Device Identifier: 07613327143744
• UDI-Public: 07613327143744
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/21/2020

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: 01/01/2025
• Device Model Number: 6425127105
• Device Catalogue Number: 6425127105
• Device Lot Number: 20007017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1