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	Rupture (2208)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: full udi is not available due to missing lot number.H6: a follow up report will be sent when the investigation is complete.
Event or Problem Description
It was reported that during a craniotomy the perforator did not stop after penetrating the skull and the dura was punctured.It was further reported that the dura was repaired after tumor removal, the procedure was completed successfully and there was no clinically significant delay.

• 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 MI NA ; EI NA
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 25019630
• Report Number: 3015967359-2026-00262
• Device Sequence Number: 15850031
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: (01)04546540716224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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