MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 6007-616-000

Device Problems Image Display Error/Artifact (1304); Imprecision (1307)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Event Description

The user facility reported the device was inaccurate during a case; the doctor reamed to 3mm short of the most medial aspect and recorded it as the new zero.During cup insertion, it was reported that there was 10mm distance to reach the new zero.Attempts are being made to obtain additional information about the event, however, no further information has been received at this time.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

The user facility reported the device was inaccurate during a case; the doctor reamed to 3mm short of the most medial aspect and recorded it as the new zero.During cup insertion, it was reported that there was 10mm distance to reach the new zero.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: ORTHOMAP® VERSATILE HIP 2.0 SOFTWARE
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9123963
• MDR Text Key: 160187668
• Report Number: 0001811755-2019-03093
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 07613327004250
• UDI-Public: 07613327004250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6007-616-000
• Device Lot Number: VERSION 2.0-3
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1