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

Catalog Number	6007-616-000
Medical Device Problem Codes	Image Display Error/Artifact (1304); Imprecision (1307)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem 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
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9123963
• Report Number: 0001811755-2019-03093
• Device Sequence Number: 14107015
• Product Code: PGW
• UDI-Device Identifier: 07613327004250
• UDI-Public: 07613327004250
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 6007-616-000
• Device Lot Number: VERSION 2.0-3
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1