MAUDE Adverse Event Report: AESCULAP AG EXCIA T FORM PROFILER SIZE 15MM; RASP FOR HIP PROSTHESIS

Model Number NT915R

Device Problem Structural Problem (2506)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Initial surgery of excia t + plasmafit.During surgery, the surgeon was not able to anchor the rasps for rotational stability.In the surgeons opinion there is a significant disproportion in geometry of the rasp.The surgery was interrupted after 40min in order to change to different model link standard c, which could be fixed safely without any problem.

Manufacturer Narrative

Corrected information: the manufacturer was incorrectly listed on the original submission.This information has been corrected on this follow up report.Visual evaluation of the received devices show no abnormalities or damage.Under certain basic conditions a risk of rotational instability could be possible.Problematic bone situation.Rotation of the rasp during application.Meanwhile modified rasps are available for use.These rasps have additional cross teeth in the approximal area which support intra operative stability.The device quality and manufacturing history records were reviewed for the available lot numbers and were found to be according to specification valid at the time of production.Based on the information available as well as a result of the investigation, the root cause of the failure is not product or design related.So far there are (b)(4) complaints with this failure.These products have been sold since 2014 and are therefore quite new.The design was tested.If this device (old design) is applied reviewed, this failure should not occur.Corrective/preventive action is not required.

• Brand Name: EXCIA T FORM PROFILER SIZE 15MM
• Type of Device: RASP FOR HIP PROSTHESIS
• Manufacturer (Section D): AESCULAP AG; 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: 5091388
• MDR Text Key: 26677378
• Report Number: 3005673311-2015-00131
• Device Sequence Number: 1
• Product Code: HWT
• 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: Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NT915R
• Device Catalogue Number: NT915R
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other