MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 105MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6725127105
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
H6; the reported product involved with this event was returned for evaluation and the reported failure of product packaging compromised was confirmed.It is likely that this damage occurred during the distribution (including handling) or storage of the product.The handling may have been more aggressive than expected or an unexpected event occurred such as external pressure while handling.The product label contains the icon "do not use if package is damaged".
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.

• Brand Name: PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 105MM)
• 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: 10254173
• Report Number: 0001811755-2020-01654
• Device Sequence Number: 2853548
• Product Code: HWE
• UDI-Device Identifier: 07613327143720
• UDI-Public: 07613327143720
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/27/2020

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: 06/01/2022
• Device Model Number: 6725127105
• Device Catalogue Number: 6725127105
• Device Lot Number: 17176017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1