MAUDE Adverse Event Report: STRYKER ZYPHR DISPOSABLE CRANIAL PERFORATOR LARGE; ADULT CRANIAL PERFORATOR

Model Number 5100-060-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 06/13/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, neuro surgeon was doing a craniotomy on this patient.During the use of the perforator for a burr hole, it did not stop when it was supposed to.It should have stopped spinning (didn't disengage) on it's own as a self stop at a certain depth, and went too far.The neurosurgeon used a codman perforator from another burr hole kit to finish the case.All similar products were removed from shelf and given to the stryker rep.Replacements were ordered from another manufacturer until issue is resolved.No harm to patient due to a clot was immediately under perforator site.

• Brand Name: ZYPHR DISPOSABLE CRANIAL PERFORATOR LARGE
• Type of Device: ADULT CRANIAL PERFORATOR
• Manufacturer (Section D): STRYKER; kalamazoo 49001
• MDR Report Key: 3893908
• MDR Text Key: 4648059
• Report Number: MW5036796
• Device Sequence Number: 1
• Product Code: HBF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/18/2014

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 Operator: Health Professional
• Device Expiration Date: 11/01/2014
• Device Model Number: 5100-060-001
• Device Catalogue Number: 5100-060-001
• Device Lot Number: 13309017
• Other Device ID Number: CE0197
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 78