MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, STRAIGHT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 6007-011-000

Device Problem Bent (1059)

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

Event Date 01/26/2017

Event Type  malfunction  

Event Description

It was reported that the tip of the device was identified as bent during an unknown time at the user facility.Although requested, no further information was provided regarding when the event took place.It was reported that there was no patient involvement or delays associated with the event.

Manufacturer Narrative

The reported event was confirmed through the visual inspection.Any physical impact to the device can cause the reported event.

Event Description

It was reported that the tip of the device was identified as bent during an unknown time at the user facility.Although requested, no further information was provided regarding when the event took place.It was reported that there was no patient involvement or delays associated with the event.

• Brand Name: POINTER, STRAIGHT
• Type of Device: ORTHOPEDIC 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6348638
• MDR Text Key: 67926321
• Report Number: 0001811755-2017-00661
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022365
• 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: 03/29/2017

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: 6007-011-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2014
• 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