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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a black watery substance came out of the device during a surgical procedure.No delay, medical intervention, or adverse consequences were reported with this event.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
In accordance with the "final guidance on medical device reporting for manufacturers" issued on november 7, 2016, stryker instruments will no longer report the hazard of leaking on the pi drive plus product lines (product code erl), as this hazard has not caused or contributed to any serious injuries in at least two years.No new mdrs will be generated for this malfunction moving forward.Additionally, supplemental records may be filed for any past reported events that are still pending evaluation or obtain new information.Should a new serious adverse event occur attributed to this hazard, mdr reporting will resume.

• 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: 22095811
• Report Number: 3015967359-2025-01053
• Device Sequence Number: 20847971
• Product Code: ERL
• UDI-Device Identifier: 07613327177350
• UDI-Public: (01)07613327177350
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152641
• 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): 08/20/2025

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): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2022
• 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