MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.1.9X77MM, WL 27MM, DENTAL SHAFT END; BIT, DRILL

Model Number	60-19426
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
The customer reported: "the drill bit broke off in the patient's bone during use.The surgeon was unable to remove it.".

• Brand Name: TWIST DRILL, DIAM.1.9X77MM, WL 27MM, DENTAL SHAFT END
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11771737
• Report Number: 0008031020-2021-00207
• Device Sequence Number: 11823341
• Product Code: HTW
• UDI-Device Identifier: 04546540247100
• UDI-Public: 04546540247100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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 Model Number: 60-19426
• Device Catalogue Number: 60-19426
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1