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 Problem Imprecision (1307)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the surgeon wanted to intentionally lengthen the operative leg by 1cm in order to achieve length equality on both sides.After securing final implants, the navigation final reduction displayed 10mm long as intended.Post operatively, the patient was actually lengthened by 2.5cm.The surgeon had to perform a revision surgery to shorten the leg by 1.5cm.There was no further medical intervention reported, or surgical delays due to the revision.

Manufacturer Narrative

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

Event Description

It was alleged by the user facility to the sales representative that during a versatile hip navigation procedure, the surgeon wanted to intentionally lengthen the operative leg by 1cm in order to achieve length equality on both sides.After securing final implants, the navigation final reduction displayed 10mm long as intended.Post operatively, the patient was actually lengthened by 2.5cm.The surgeon had to perform a revision surgery to shorten the leg by 1.5cm.There was no further medical intervention reported, or surgical delays due to the revision.

• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7085209
• MDR Text Key: 93804244
• Report Number: 0001811755-2017-02402
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6007-616-000
• Device Lot Number: VERSION: 2.0-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention