MAUDE Adverse Event Report: STRYKER CORPORATION ZYPHR; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number	5100060001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The disposable zyphr cranial perforator (large) by stryker did not stop when appropriate and went into the patient's dura on the left side.Dura was torn, but was repaired during surgery.It did not plunge into the brain tissue.A new perforator was opened for the right side.Ref #-5100-060-001, lot#- 25237057, exp- 08/01/2028.

• Brand Name: ZYPHR
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 24710778
• Report Number: 24710778
• Device Sequence Number: 5652415
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: (01)04546540716224(17)280801(10)25237057
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2026
• Report Date (Section F): 03/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5100060001
• Device Catalogue Number: 5100-060-001
• Device Lot Number: 25237057
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/19/2026