MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2108 SERIES SAGITTAL BLADE, NO OFFSET (18.6 X 1.24 X 105MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2108185000
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that there was a potential sterility breach on the packaging of the device, a small hole was found in the pack during a hip procedure.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully using a back-up device.
Additional Manufacturer Narrative
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, a small hole was found in the pack during a hip procedure.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully using a back-up device.

• Brand Name: 2108 SERIES SAGITTAL BLADE, NO OFFSET (18.6 X 1.24 X 105MM)
• 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: 9570153
• Report Number: 0001811755-2020-00032
• Device Sequence Number: 438660
• Product Code: GFA
• UDI-Device Identifier: 04546540042279
• UDI-Public: 04546540042279
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 03/13/2020

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: 07/01/2022
• Device Model Number: 2108185000
• Device Catalogue Number: 2108185000
• Device Lot Number: 17186017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1