MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ELECTRIC HANDSWITCH- LEFT HANDED; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5400121000S1
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a metal rod fell out of the device during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that a metal rod fell out of the device during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
H3; the device was not accessible for evaluation; therefore, a root cause could not be determined for the event.H3 other text : product not accessible for evaluation.

• Brand Name: ELECTRIC HANDSWITCH- LEFT HANDED
• 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: 9647353
• Report Number: 0001811755-2020-00350
• Device Sequence Number: 14245850
• Product Code: ERL
• UDI-Device Identifier: 07613154495634
• UDI-Public: 07613154495634
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 5400121000S1
• Device Catalogue Number: 5400121000S1
• Device Lot Number: 18232
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1