ZYPHR 5400-050-000 5100-060-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-06 for ZYPHR 5400-050-000 5100-060-001 manufactured by Stryker.

Event Text Entries

[3551178] The doctor was using the disposable cranial perforator connected to a core powered instrument driver box when the perforator failed to automatically stop. We have had at least 3 other reports of this drill perforator clutch not engaging or disengaging over the past two months. A different manufacturer's perforator was removed from our operating room and replaced with this perforator with a similar problem of the "clutch not engaging". There have not been any serious patient injuries as a result of this identified and reported problem, however, the drill did create a small tear in a patient's brain dura. This injury was not considered serious, nor did it require repair, but this was concerning. The operating room reported this to the company and additional training was provided to the neurosurgery physicians (attending and residents) who use this drill regularly. This product is used only within the operating room so the additional training was able to include all known operators of the drills. What was the original intended procedure? The stryker zyphr tm disposable cranial perforator large 14/1 1mm(perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3169342
• MDR Report Key: 3169342
• Date Received: 2013-06-06
• Date of Report: 2013-06-05
• Date of Event: 2013-05-16
• Report Date: 2013-06-05
• Date Reported to FDA: 2013-06-06
• Date Reported to Mfgr: 2013-06-14
• Date Added to Maude: 2013-06-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZYPHR
• Generic Name: DRILLS, BURRS
• Product Code: HBG
• Date Received: 2013-06-06
• Model Number: 5400-050-000
• Catalog Number: 5100-060-001
• Lot Number: 3140501131210173N
• ID Number: *
• Operator: PHYSICIAN
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER
• Manufacturer Address: 4100 E. MILHAM AVENUE KALAMAZOO MI 49001 US 49001

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-06-06