MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS Q TIBIA/DISTAL FEMUR CUTTING GUIDE

Model Number NS334R

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2016

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).When using the navigated approach during a knee surgery, the display of resection and the slopes is not consistent with the actual values.The error relates to the tibia and the femur height.Result was too much bone resected.

Manufacturer Narrative

An external inspection with improvised methods did not achieve any tangible results.Furthermore an internal inspection with the provided devices was conducted.In this investigation which was implemented in the production and development department was included a measurement on the golden bench.No abnormalities or deviations were found.No failure or fault could be determined.The product does not require batch management, a review of the device quality and manufacturing history records is not possible.After several discussions with different specialist and departments a root cause for the mentioned failure could not be determined.The results of the investigation of the root cause of the failure is most probably not product related.There is no registered failure like this in the system.Further more the failure cause could not be determined, therefore a systematical problem is excluded.A capa is not necessary.Additional information: components in use listed as concomitant devices are: ns334r / iq tibia/distal femur cutting guide, fs626r / orthopilot tka rb-adapter modular.

• Brand Name: Q TIBIA/DISTAL FEMUR CUTTING GUIDE
• Type of Device: CUTTING GUIDE
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5759356
• MDR Text Key: 48464274
• Report Number: 3005673311-2016-00107
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

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
• Device Operator: No Information
• Device Model Number: NS334R
• Device Catalogue Number: NS334R
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/23/2016
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR