MAUDE Adverse Event Report: AESCULAP AG QUINTEX SEMICONSTRAINED SCREW 4.0X16MM; SPINE SURGERY

Model Number SC503T

Device Problems Material Fragmentation (1261); Device Damaged by Another Device (2915)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

It was reported that there was an issue with sc503t - quintex semiconstrained screw 4.0x16mm.According to the complaint description, during a surgical cervical plate placement, a metallic filament was noted.This occurred during screw implantation.There was unknown patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Investigation results: visual investigation: unfortunately, we received only a screw and a metal chip.We made an microscopical investigation of the received metal- chip.In terms of shape and length, it could be a chip that occurs when part of the screw thread is sheared off when the screw is screwed in.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 no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability 1(5) of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: without the involved plate available for investigation, a definitive root cause for the occurrence of the shaving cannot be determined.The reason for shavings like the present in the past (intra operative cases) was a not correct placed screw in the screw slot of the plate.The thread of the screw was shaved off at the edge of the screw slot of the plate.The edge of the plate shows especially signs of scratches and wear too in such cases.The surgical technique points out, that the quintex screw may be damaged or insufficiently locked if it is not correctly engaged in the hold or slot of the quintex plate.Based upon the investigations results a capa is not necessary.

• Brand Name: QUINTEX SEMICONSTRAINED SCREW 4.0X16MM
• Type of Device: SPINE SURGERY
• 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: 14427778
• MDR Text Key: 291969466
• Report Number: 9610612-2022-00150
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K100243
• 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: 09/06/2023

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: SC503T
• Device Catalogue Number: SC503T
• Device Lot Number: 52356840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1