MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SUCTION TUBE, 2.7MM LH FRONTAL SINUS; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6001-088-427

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

It was reported that the tip of the 2.7mm right posterior fossa suction tube was bent during testing.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

During failure analysis, the reported event that the suction tube tip was bent was confirmed during the visual inspection and production software.During the device evaluation, we were unable to determine what caused the bent tip.It is possible rough or improper handling led to the bent tip.The device was discarded by the manufacturer following evaluation.

Event Description

It was reported that the tip of the 2.7mm right posterior fossa suction tube was bent during testing.There was no patient involvement and no adverse consequences associated with the device.

• Brand Name: SUCTION TUBE, 2.7MM LH FRONTAL SINUS
• 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: 3765664
• MDR Text Key: 4636295
• Report Number: 0001811755-2014-01445
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6001-088-427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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