MAUDE Adverse Event Report: AESCULAP AG S4 ELEMENT MIS POLYAXIAL SCREW 6.5X40MM; S4 ELEMENT IMPLANTS

Model Number ST063T

Device Problem Fitting Problem (2183)

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

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 st063t - s4 element mis polyaxial screw 6.5x40mm.According to the complaint description, the surgeon found the screw nail and head couldn't be fitting tightly when just open the box.Sample is available for investigation.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: we made a visual inspection of the screw parts, especially the insert.The screw itself exhibit damages and deformations in the hexagon.The body shows no damages or abnormalities.The insert shows bent catch noses.It is plain to see, that the plate with the catch nose is bent.With this nose out of alignment a reliable catch of the insert in the body is no longer given.For a better comprehension, an excerpt of the construction drawing is attached.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Conclusion and measures / preventive measures: without further knowledge about the circumstances, we assume, that the plate was deformed during the surgery by wrong handling.The reason for this is probably a not proper attached hex key tip.The damaged / deformed hexagon in the screw head is a sure hint for this assumption.According to the batch history record the product left aag in a condition according to specification.A material defect or a manufacturing error can be excluded.Based upon the investigations results a capa is not necessary.

• Brand Name: S4 ELEMENT MIS POLYAXIAL SCREW 6.5X40MM
• Type of Device: S4 ELEMENT IMPLANTS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11400024
• MDR Text Key: 249478348
• Report Number: 9610612-2021-00193
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K090657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST063T
• Device Catalogue Number: ST063T
• Device Lot Number: 52603804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• 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