MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.5MM RADIOLUCENT DRILL BIT; BIT, SURGICAL

Model Number	4200355035
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	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported during a surgical procedure that there was a potential sterility breach on the packaging of the device.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported during a surgical procedure that there was a potential sterility breach on the packaging of the device.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.

• Brand Name: 3.5MM RADIOLUCENT DRILL BIT
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9950052
• Report Number: 0001811755-2020-00900
• Device Sequence Number: 2319993
• Product Code: GFG
• UDI-Device Identifier: 04546540217165
• UDI-Public: 04546540217165
• Combination Product (Y/N): N
• 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): 06/03/2020

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: 12/01/2024
• Device Model Number: 4200355035
• Device Catalogue Number: 4200355035
• Device Lot Number: 19344017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1