MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6000-999-004

Device Problem Disassembly (1168)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2016

Event Type  malfunction  

Event Description

It was reported that after a surgical procedure conducted at the user facility the instrument broke into four pieces when detaching it from another instrument.No patient involvement or procedural delays were reported with this event.

Manufacturer Narrative

The reported event that the device broke into 4 pieces was confirmed by the complaint specialist during device evaluation; during the visual inspection the securing screw at the end of the tightening screw was found to have broken off, allowing the entire device to be disassembled.Any physical impact to the device can cause the reported event.

Event Description

It was reported that after a surgical procedure conducted at the user facility the instrument broke into four pieces when detaching it from another instrument.No patient involvement or procedural delays were reported with this event.

• Brand Name: NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 13 TO 20MM
• 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6188448
• MDR Text Key: 62794570
• Report Number: 0001811755-2016-02871
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6000-999-004
• Device Lot Number: A/11/2013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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