MAUDE Adverse Event Report: AESCULAP AG QUINTEX SCREW DRIVER; SPINE SURGERY

Model Number SC432R

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  Injury  

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 sc432r-quintex screw driver.According to the complaint description, both screwdrivers do not retain hold of the quintex screws mounted on them.The surgery used bone wax to be ensure that the screws did not displace off the screwdriver.There was no described patient harm.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00946 ((b)(4) sc432r).

Manufacturer Narrative

Investigation results: visual investigation: at the first sight the screwdriver shows no damages.At a closely look, we found slight wear at the tip.We made a visual inspection of the screwdriver, especially the tip.Here we found slight wear.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there is one similar complaints against the same lot number(s) in this xc.The review of risk assessment revealed that the overall risk level (severity 4(5) probability of occurrence 3(10)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.The tip of the screwdriver shows normal signs of wear and tear, which occur during the years of usage (this screwdriver was manufactured in 2015).This is no failure of the product or manufacturing.Based upon the investigations results there is capa is not necessary.Associated medwatches: 9610612-2020-00946.9610612-2020-00947.

• Brand Name: QUINTEX SCREW DRIVER
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11127051
• MDR Text Key: 226060581
• Report Number: 9610612-2020-00947
• Device Sequence Number: 1
• Product Code: HXX
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SC432R
• Device Catalogue Number: SC432R
• Device Lot Number: 52184436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention