MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG ADAPT 2.0 FOR GAMMA3 SW; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	0101-2900
Medical Device Problem Codes	Image Display Error/Artifact (1304); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During testing of the device, significant misrepresentations and mis-measurements occurred.The device is reported to be new.Surgical delay of 30min.Not longer.This resulted in triple increase in radiation exposure, normally radiation time for gamma3 nail in this hospital is 12-13 seconds, in this surgery 40 seconds.No other patient impact.
Additional Manufacturer Narrative
Correction: refer to d4 - catalog & lot number.The reported event was confirmed based on a logfile analysis.The logfile shows an implant misalignment at the beginning of the case which was not shown in adapt because the markers were not visible.The software displayed an instruction to solve the error, but the user did not follow this instruction.Based on the misalignment, the user chose wrong screw measurement which was tried to be resolved only in the anterior-posterior view, which lead to a wrong alignment in the medial-lateral view.Necessary for that end have been several more x-rays.At the end of the usage of the system, the femoral head was not detected automatically which was caused by low quality x-rays.Based on a sme consultation, an implant movement and the disregarded initial instruction of the software to handle the misalignment of the implant may cause or contribute to the reported event.Furthermore, low quality x-rays caused that the femoral head was not detected automatically and lead the user to change the surgery method.If any further information is provided, the investigation report will be updated.
Event or Problem Description
During testing of the device, significant misrepresentations and mismeasurements occurred.The device is reported to be new.Surgical delay of 30min.Not longer.This resulted in triple increase in radiation exposure, normally radiation time for gamma3 nail in this hospital is 12-13 seconds, in this surgery 40 seconds.No other patient impact.

• Brand Name: ADAPT 2.0 FOR GAMMA3 SW
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 9417005
• Report Number: 0008031020-2019-02033
• Device Sequence Number: 2450400
• Product Code: OLO
• UDI-Device Identifier: 07613327312393
• UDI-Public: 07613327312393
• Combination Product (Y/N): N
• PMA/510(K) Number: K173946
• 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): 03/26/2020

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: Health Professional
• Device Model Number: 0101-2900
• Device Catalogue Number: 0101-0001
• Device Lot Number: V2.0-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1