MAUDE Adverse Event Report: AESCULAP AG CUP INSERTION INSTR.W/THREAD M8X1 CVD; HIP ENDOPROSTHETICS

Model Number NT411R

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the cup insertion instrument.In the operating room, while inserting the cup, the insertion device broke.The doctor was able to remove the device from the cup and the case went on as scheduled.There was a surgical delay of less than 5 minutes.Additional intervention was not required; there was no patient harm.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: the complained device is available in a decontaminated condition for investigation.Investigation: the pin of the cup inserter is broken.The components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".The pin of the cup inserter which holds the cardan joint in place is broken.Both breakage surface show no material deviations like blowholes or foreign material inclusions.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is probably usage related.Rationale: according to the quality standard and dhr files a material defect and production error was not found.Probably the pin is broken during insertion the cup when the screwdriver (nt412r) was connected to the instrument (nt411r) to press against the acetabular cup at the time of impact.This may have contributed to excessive load on the pin of the instrument.Furthermore it could be possible that the user turned the cup opposite the complete impactor for increase in torque when the screwdriver still stuck in the instrument (warning information in the ifu).Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.Also additional information has been added to d4, d10 and h4: batch number, date returned to manufacturer and production date after receipt of the article.

Event Description

New information has been added to d4, d10 and h4: batch number, date returned to manufacturer and production date could be determined after receipt of the article.

• Brand Name: CUP INSERTION INSTR.W/THREAD M8X1 CVD
• Type of Device: HIP ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9468756
• MDR Text Key: 170792359
• Report Number: 9610612-2019-00846
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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
• Device Lot Number: 51996356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1