MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZYPHR DISP CRAN PERF LRG 14/11; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

Catalog Number	5100060001
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Codes	Rupture (2208); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 5 events were reported for this quarter.Product return status: 5 device investigation types have not yet been determined.Additional information: 5 devices were labeled for single-use.5 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 5 malfunction events in which the device failed to auto-stop.- 1 event had the problem identified before clinical use/exposure; there was no patient involvement.- 3 events had patient involvement; no patient impact.- 1 event had insufficient information received.
Event or Problem Description
This report summarizes 4 malfunction events in which the device failed to auto-stop.- 1 event had the problem identified before clinical use/exposure; there was no patient involvement.- 3 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h1, h6, h11 5 events were previously reported during the reporting period; however, - 1 previously reported event in this report was reported under mfr report # 3015967359-2025-00404.- 4 previously reported events are included in this follow-up record.Product return status 1 device was received.3 devices were not available for evaluation.

• Brand Name: ZYPHR DISP CRAN PERF LRG 14/11
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• 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 ; 2693237700
• MDR Report Key: 21200838
• Report Number: 3015967359-2025-00163
• Device Sequence Number: 20982281
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: 04546540716224
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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
• Device Catalogue Number: 5100060001
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown