MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 9.1MM X 7.9MM FLUTED DRUM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5130020991
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
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 with no patient involvement.It was further reported that there was no delay, adverse consequences or medical intervention as a result of this event.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Additional Manufacturer Narrative
H6: 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 with no patient involvement.It was further reported that there was no delay, adverse consequences or medical intervention as a result of this event.

• Brand Name: 9.1MM X 7.9MM FLUTED DRUM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16672549
• Report Number: 3015967359-2023-00661
• Device Sequence Number: 6445897
• Product Code: HBE
• UDI-Device Identifier: 04546540079480
• UDI-Public: 04546540079480
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• 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): 07/17/2023

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: 5130020991
• Device Catalogue Number: 5130020991
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown