MAUDE Adverse Event Report: STRYKER GMBH WEB APPLICATION HOFFMANN LRF; UNKNOWN

Catalog Number	983031
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
When computing a correction plan with more than one correction per day and "correct axial first" selected, the hoffmann lrf software erroneously computes the axial portion of the correction, resulting in a correction plan that would be faster than intended.The surgeon overrode the (erroneous) correction time with his own calculations.We provide a surgeon override feature in case they wish to do that.
Event or Problem Description
When computing a correction plan with more than one correction per day and "correct axial first" selected, the hoffmann lrf software erroneously computes the axial portion of the correction, resulting in a correction plan that would be faster than intended.The surgeon overrode the (erroneous) correction time with his own calculations.We provide a surgeon override feature in case they wish to do that.
Additional Manufacturer Narrative
The reported event that web application hoffmann lrf was alleged of being 'not functional' could be confirmed, since the reported outputs were replicated in software.Based on investigation, the root cause was attributed to be design related.The failure was caused by wrong calculations process.Therefore, nc and capa have been initiated to correct deviations.The nominated risks are not only valid for the hoffmann lrf hexapdod system but for all hexapod six-axis external ring fixator systems.From a clinical point of view the nominated risks are acceptable when weighted against the benefits of the devices in question.Wrong or excessive correction, correction delivered too early, correction delivered in wrong direction, or at an excessive distraction rate, the struts will need to be reoriented into a corrected position.With no web app, a correction plan will need to be created and/or applied, the frame has to be corrected, this will require adjustments to the frame.This is a normal process and usually does not cause significant harm.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: WEB APPLICATION HOFFMANN LRF
• Common Device Name: UNKNOWN
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7723510
• Report Number: 0008031020-2018-00523
• Device Sequence Number: 1018241
• Product Code: KTT
• UDI-Device Identifier: 07613327297751
• UDI-Public: 07613327297751
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: Health Professional
• Device Catalogue Number: 983031
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other