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

Catalog Number 5100060001

Device Problems Use of Device Problem (1670); Failure to Auto Stop (2938); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 12/03/2016

Event Type  Injury  

Manufacturer Narrative

Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop and nicked the dura.It was also reported that there was surgical delay of 2 minutes.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

The perforator bit was returned for evaluation and the disengagement mechanism within the perforator was tested and functioned as intended.The reported failure of failure to disengage could not be confirmed.It was reported in this event that some "rocking" of the perforator was applied during use.The ifu #(b)(4)rev.D provides the following warning when using the perforator; "do not rock or bind the perforator during use.Failure to comply may result in serious patient injury or death.".

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop and nicked the dura.It was also reported that there was surgical delay of 2 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: 6192827
• MDR Text Key: 62955065
• Report Number: 0001811755-2016-02884
• Device Sequence Number: 1
• Product Code: HBF
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 5100060001
• Device Lot Number: 16297067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2016
• 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
• Treatment: 5400210060, SN (B)(4)
• Patient Outcome(s): Other