MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5100060001

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

The device is available for return.A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.

Event Description

It was reported that during a cranial procedure, metal shavings were observed on the patient.It was also reported that there was surgical delay of 5 minutes.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

The product was returned for evaluation.The perforator product reported involved with this event was returned for evaluation.Score marks were observed on the surface of the returned perforator.From the analysis carried out it appears the markings present on the returned device are a consequence of the device contacting a metal instrument while in use.The ifu #(b)(4) provides indication for use as follows; "the stryker zyphr disposable cranial perforator, large 14/11 mm (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 3 mm thick.".

Event Description

It was reported that during a cranial procedure, metal shavings were observed on the patient.It was also reported that there was surgical delay of 5 minutes.It was further reported that the procedure was completed successfully.

• Brand Name: ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 6666189
• MDR Text Key: 78373065
• Report Number: 0001811755-2017-01342
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 4546540716224
• UDI-Public: (01)4546540716224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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 Catalogue Number: 5100060001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1