MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS IQ TIBIA/DISTAL FEMUR CUTTING GUIDE; KNEE ENDOPROSTHETICS

Model Number NS334R

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation on-going.

Event Description

(b)(6).It was reported on two different occasions the pin broke off in the distal femur.The first incident the surgeon tried to retrieve the broken pin head but could not, the surgeon made the decision to leave it in the patients.The patient was informed of the incident and is doing well.The second incident the surgeon was able to retrieve the broken pin head from the patient.There was no harm to the patient.No delay in surgery when the surgeon removed the broken pin from the patient.There was also an incident that the pin was stuck in a cutting block ns334.All med watch submissions related to this report are: 3005673311-2016-00198, 3005673311-2016-00199, 3005673311-2016-00200.

Manufacturer Narrative

Investigation: no product is at hand.Conclusion and root cause: no product available and therefore an analysis is not possible, but we assume based on the information available, the root cause of the failure is design related.Rational: regarding cc (b)(4) there is the possibility for the same root cause of the failure.The pin and the inner surface of one hole may have been cold welded.This caused by the following reason: "the most likely root cause of the failure is that the design of the saw guide is causing damage to the pin upon insertion which is resulting in the particles from the damage causing cold welding.R&d have found the same cause." capa (b)(4) was opened.

• Brand Name: IQ TIBIA/DISTAL FEMUR CUTTING GUIDE
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; 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: 6141215
• MDR Text Key: 61405266
• Report Number: 3005673311-2016-00200
• 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
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/14/2016
• Date Manufacturer Received: 11/04/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other