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	05/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device was discarded.
Event or Problem Description
It was reported that during a craniotomy procedure, the drill bit broke and remained inside the patient¿s skull bone.It was also reported that the surgeon did not realize the breakage at the time.It was further reported that a week later, a revision surgery was performed to remove the broken fragment.
Event or Problem Description
It was reported that during a craniotomy procedure, the drill bit broke and remained inside the patient¿s skull bone.It was also reported that the surgeon did not realize the breakage at the time.It was further reported that a week later, a revision surgery was performed to remove the broken fragment.
Additional Manufacturer Narrative
H6; the reported event, for drill breakage, was confirmed by way of photographic evidence provided.The drill reported involved in this event was not returned for evaluation.Without the device, the root cause cannot be determined.H3 other text : device discarded by customer.

• 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: 10153394
• Report Number: 0001811755-2020-01455
• Device Sequence Number: 2101433
• 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): 07/24/2020

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?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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