MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.2MM X 18.3MM METAL CUTTING HELIOCOIDAL RASP; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5120080030
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
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 during inspection at the hospital, a hole was identified on the packaging of the device.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.
Event or Problem Description
It was reported that during inspection at the hospital, a hole was identified on the packaging of the device.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.

• Brand Name: 3.2MM X 18.3MM METAL CUTTING HELIOCOIDAL RASP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11757484
• Report Number: 3015967359-2021-00756
• Device Sequence Number: 3157970
• Product Code: HBE
• UDI-Device Identifier: 04546540078728
• UDI-Public: 04546540078728
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 03/01/2026
• Device Model Number: 5120080030
• Device Catalogue Number: 5120080030
• Device Lot Number: 21063027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1