MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.7MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820103017
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
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 after a craniotomy procedure, a surgeon noticed a metal fragment in the skull bone on a ct image.It was also reported that the surgeon performed a surgery to remove the fragment the next day.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that after a craniotomy procedure, a surgeon noticed a metal fragment in the skull bone on a ct image.It was also reported that the surgeon performed a surgery to remove the fragment the next day.

• Brand Name: 1.7MM WIRE PASS DRILL BIT
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10178414
• Report Number: 0001811755-2020-01511
• Device Sequence Number: 19473179
• Product Code: HBE
• UDI-Device Identifier: 04546540362438
• UDI-Public: 04546540362438
• Combination Product (Y/N): N
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5820103017
• Device Catalogue Number: 5820103017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention