MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PI DRIVE PLUS MOTOR; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5407300000
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	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a small piece fell out of the device during a surgical procedure.No patient impact was reported.Attempts are being made to obtain additional information from the user facility.
Additional Manufacturer Narrative
D4: full udi not provided as serial number unknown.
Additional Manufacturer Narrative
This event is not reportable for this device.Upon follow-up it was specified that the piece came from the attachment, not the handpiece.Based on the date the additional information was received, the attachment will be reported through vmsr for q3 2025.
Event or Problem Description
It was reported that a small piece fell out of the device during a surgical procedure.No patient impact was reported.Upon follow-up it was specified that the piece came from the attachment, not the handpiece.

• Brand Name: PI DRIVE PLUS MOTOR
• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22185680
• Report Number: 3015967359-2025-01102
• Device Sequence Number: 15542701
• Product Code: ERL
• UDI-Device Identifier: 07613327177350
• UDI-Public: (01)07613327177350
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K152641
• 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): 07/28/2025

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 Catalogue Number: 5407300000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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