MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRO DRILL 5:1 REDUCER; DRILL, BONE, POWERED

Model Number	7400015043
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Correction: d9, h3.Additional info h6 h3 other text : device not returned.
Event or Problem Description
The user facility reported that the device overheated during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: MICRO DRILL 5:1 REDUCER
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15293308
• Report Number: 3015967359-2022-01687
• Device Sequence Number: 6304548
• Product Code: DZI
• UDI-Device Identifier: 07613327503883
• UDI-Public: 07613327503883
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: 7400015043
• Device Catalogue Number: 7400015043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown