MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHO GRIP KNEE POINTER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 6003-012-000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  malfunction  

Event Description

It was reported that the tip of the device was found to be bent during a surgical procedure.No adverse consequences or procedural delays were reported to have taken place.

Manufacturer Narrative

Additional information: the reported event that the tip of the device was bent was confirmed by the device evaluation.Any physical impact to the navigated instrument can cause product damage or operational failure due to battery movement.

Event Description

It was reported that the tip of the device was found to be bent during a surgical procedure.No adverse consequences or procedural delays were reported to have taken place.

• Brand Name: ORTHO GRIP KNEE POINTER
• 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: 6235813
• MDR Text Key: 64239896
• Report Number: 0001811755-2017-00034
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022579
• 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: 02/23/2017

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: 6003-012-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2010
• 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