MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6007-003-000

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 03/16/2015

Event Type  malfunction  

Event Description

It was reported that during a hip replacement procedure at the healthcare facility, the coupling for orthopedic anchoring system, which was holding the tracker, became loose during cup impaction.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

The device was not available for evaluation.

Event Description

It was reported that during a hip replacement procedure at the healthcare facility, the coupling for orthopedic anchoring system, which was holding the tracker, became loose during cup impaction.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

• Brand Name: COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM
• 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 (MDR); boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4673015
• MDR Text Key: 5619417
• Report Number: 0001811755-2015-01306
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K022365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6007-003-000
• Device Lot Number: D/01/2011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• 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