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

Catalog Number 6001-020-000

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

It was reported by the customer that the instrument was found broken and bent after a procedure.The device breaking during a procedure could cause a piece to fall into a surgical site and cause infection or patient harm.There was no known patient involvement or procedural delays associated with the event.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

It was reported by the customer that the instrument was found broken and bent after a procedure.The device breaking during a procedure could cause a piece to fall into a surgical site and cause infection or patient harm.There was no known patient involvement or procedural delays associated with the event.

• Brand Name: POINTER, NASAL
• 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-791 11
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7436728
• MDR Text Key: 105696473
• Report Number: 0001811755-2018-00602
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6001-020-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2017
• 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