MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6000-999-003
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pelvic acetabular osteotomy navigation procedure, a navlock clamp attached to the osteotome was impacted with a hammer and a washer on the navlock broke into three pieces.The surgeon was able to remove the fragments ensuring no remaining fragments were left in the patient.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that during a pelvic acetabular osteotomy navigation procedure, a navlock clamp attached to the osteotome was impacted with a hammer and a washer on the navlock broke into three pieces.The surgeon was able to remove the fragments ensuring no remaining fragments were left in the patient.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: NAVLOCK, UNIVERSAL TRACKER ADAPTER FOR INSTRUMENTS FROM 7 TO 13MM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7800870
• Report Number: 0001811755-2018-01603
• Device Sequence Number: 16629250
• Product Code: HAW
• UDI-Device Identifier: 04546540391919
• UDI-Public: 04546540391919
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K993239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 6000-999-003
• Device Lot Number: A-06-2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1