MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP U SERIES STRAIGHT MEDIUM M" ATTACHMENT"; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5100010050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer representative reported that the device disassembled during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The manufacturer representative reported that the device disassembled during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: U SERIES STRAIGHT MEDIUM M" ATTACHMENT"
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10900430
• Report Number: 0001811755-2020-03288
• Device Sequence Number: 13758132
• Product Code: ERL
• UDI-Device Identifier: 04546540074492
• UDI-Public: 04546540074492
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 5100010050
• Device Catalogue Number: 5100010050
• Device Lot Number: 90900
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/31/2020
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1