MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PI DRIVE 2 MOTOR; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	5407150000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a router broke during a procedure.It was also reported that the procedure was completed successfully with no adverse consequences.No further information available at this time.Information regarding medical intervention and surgical delay has been requested from the customer.
Additional Manufacturer Narrative
D4: full gtin unavailable as serial number not provided.
Additional Manufacturer Narrative
B5: additional detail.D4: serial number and udi updated as serial number provided.
Event or Problem Description
It was reported that while disassembling the system after use in a craniotomy, after the attachment had been disconnected but the cutting accessory was still installed, the handpiece was accidentally activated by the surgeon and the cutting accessory broke.The procedure was completed successfully with no adverse consequences.No further information was provided.

• Brand Name: PI DRIVE 2 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: 22052818
• Report Number: 3015967359-2025-01027
• Device Sequence Number: 14791284
• Product Code: ERL
• UDI-Device Identifier: 07613327504019
• UDI-Public: (01)07613327504019
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K141935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 5407150000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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