MAUDE Adverse Event Report: AESCULAP AG IQ TIBIA/DISTAL FEMUR CUTTING GUIDE; INSTRUMENTS FOR KNEE ENDOPROST

Model Number NS334R

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: a visual inspection of the femur cutting guide (ns334r) and the threaded pin (np586r) was made.A visual inspection revealed visible damage and visible helix traces, also metal powder was discovered.Grooves were found in both boreholes.Also grooves in both boreholes were found.Examination of the boreholes was made with a control gauge and it was determined that they and not complying with the specifications.The boreholes no longer have the initial diameter through material throw-up and using traces.Batch history review: ns334r: the device quality and manufacturing history records have been checked for the lot number (4508169307) and found to be according to the specification, valid at the time of production.Three similar incidents have been filed with a product from the batch (4508169307).Conclusion and root cause: the root cause of the problem is most probably usage related.Rationale: investigations lead to the assumption that the grooves in both boreholes and metal powder were caused by a usage error due to a material throw-up of the pin.The boreholes no longer have the initial diameter through material throw-up and using traces.Particles or forces applied during corrections while navigating may have led to a material throw-up.The quirks and visible helix traces may have been caused by the grooves, material throw-up and the additional movement through using the pin.There is a possibility for pre-damage or similar due to previous surgeries.If the instruments are in such poor condition they should no longer be used.Due to a material throw-up and grooves in the boreholes, there is the possibility that the pin and the inner surface of the hole could have been cold welded.We cannot determined the exact cause for the visible damaged tip.According to the instructions for use (ifu) the following points and warnings much be observed: excerpt from ifu: prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.Do not use the product if it is damaged or defective.Set aside the product if it is damaged.Replace any damaged components immediately with original spare parts.A capa was initiated.Associated medwatch: 9610612-2019-00076.

Event Description

It was reported intraoperatively the pins stuck in cutting guide.During a surgical procedure it was reported the threaded pin got stuck in the cutting guide.Per the information available, there was no negative consequence to the patient and no reported delay in the procedure.Additional information was requested regarding patient outcome and any additional medical intervention required.

• Brand Name: IQ TIBIA/DISTAL FEMUR CUTTING GUIDE
• Type of Device: INSTRUMENTS FOR KNEE ENDOPROST
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8371005
• MDR Text Key: 139339789
• Report Number: 9610612-2019-00068
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NS334R
• Device Catalogue Number: NS334R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/06/2019
• Date Manufacturer Received: 02/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1