MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6000-011-000

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported that the tip of the large pointer was bent during testing at the user facility.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

The reported event that the pointer tip was bent was duplicated; during visual inspection it was confirmed that the device had a bent tip.The pointer could be validated and used for navigation despite the visual damage.It is possible that bending forces caused the tip to bend.The pointer was repaired and put back into stryker stock.

Event Description

It was reported that the tip of the large pointer was bent during testing at the user facility.There was no patient involvement and no adverse consequences associated with the device.

• Brand Name: LARGE POINTER
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3571776
• MDR Text Key: 4446886
• Report Number: 0001811755-2014-00127
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993239
• 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: 12/18/2013

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: 6000-011-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 01/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1