MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS PLASMAFIT PLUS 7 CUP ¿CAP SIZE 54MM HCUP INSERTION INSTR.W/THREAD M8X1 CVD; HIP ENDOPROSTHETICS

Model Number NT411R

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

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

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).It was reported that during a tha (total hip arthroplasty) an instrument could not be removed from the cup.After reaming the surgeon set the cup with a curve impactor connected to a driver.Once the surgeon had the cup in its place he attempted to remove the impactor fro the cup.Even though the impactor and the cup was in place, now the impactor could not be removed.The cup had to be removed to remove the impactor.The procedure had to be completed by using another cup and a straight impactor.There was no harm to the patient reported.No surgery delay.All medwatch submissions related to this report are: 9610612-2017-00322.Components in use listed as concomitant devices are: nt411r / cup insertion instr.With thread m8x1 cvd.Nt412r / screw driver sw4.5.

Manufacturer Narrative

Investigation all devices were investigated visually.The thread of the impactor as well as the thread of the plasmafit plus 7 cup shows no damages or any surface defects.The working end of the screw driver sw4.5 also shows no significant damages.Batch history review the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause based on the information available as well as a result of our investigation the root cause of the failure is most probably user related.A possible reason for this failure could be that the surgeon applied the devices with a too much torque.Rational this is the second complaint regarding this failure.There are several cases in which the impactor released during surgery.Furthermore there are no hints for material or product deviations.Corrective action according to sop (b)(4) a capa is not necessary.

• Brand Name: PLASMAFIT PLUS 7 CUP ¿CAP SIZE 54MM HCUP INSERTION INSTR.W/THREAD M8X1 CVD
• Type of Device: HIP 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: 6623100
• MDR Text Key: 77426607
• Report Number: 9610612-2017-00323
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/14/2017

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: Health Professional
• Device Model Number: NT411R
• Device Catalogue Number: NT411R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/06/2017
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 05/12/2017
• Supplement Dates FDA Received: 07/17/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR