MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp ZYPHR DISP CRAN PERF LRG 14/11; Drills, burrs, trephines & accessories

Catalog Number	5100060001
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the perforator malfunctioned while in use, stopping 3-4 times and plunging through dura.The event resulted in unexpected/prolonged care and and a delay in treatment/therapy.No further information available at this point.
Additional Manufacturer Narrative
H6: a follow up report will be sent when the investigation is complete.

• Brand Name: ZYPHR DISP CRAN PERF LRG 14/11
• Common Device Name: Drills, burrs, trephines & accessories
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Ireland; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 50587752
• Report Number: 3015967359-2026-00476
• Device Sequence Number: 10226101
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: (01)04546540716224(17)290401(10)26115017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5100060001
• Device Lot Number: 26115017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown