MAUDE Adverse Event Report: AESCULAP AG QUINTEX SEMICONSTRAINED SCREW 4.0X16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	SC503T
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a quintex semiconstrained screw 4.0x16mm (part # sc503t) was used during an anterior cervical fusion procedure performed on (b)(6) 2021.According to the complainant, while attempting to seat the 16 millimeter (mm) quintex screw, the inner silver bushing kept popping out.This occurred on three (3) consecutive 16mm screws (ref.Associated mdr id 9610612-2021-00428).The physician switched to the 14mm screws and was able to continue and successfully complete the procedure.Reportedly, the problem occurred prior to the screw being fully seated into the plate and while the screwdriver was still engaged in the screw.The complaint device was returned to the manufacturer for evaluation.There was no surgical delay.No patient complications occurred as a result of the event.The malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2021-00428 ((b)(4) + sc503t).
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: visual investigation: the investigator made a visual inspection of the screws, especially their heads and the segments.At one of screw the segments bent outwards as well as by the other ones.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 6(10) probability of occurrence5(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.Without further knowledge about the circumstances we suspect that the screwdriver was appointed and / or driven with a too acute angle.This is the basic cause in ring losing causes like this.The bent segments are further clues that support this thesis.Based upon the investigations results a capa is not necessary.Associated medwatch-reports: 9610612-2021-00428 (400513986 + sc503t).

• Brand Name: QUINTEX SEMICONSTRAINED SCREW 4.0X16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11971029
• Report Number: 9610612-2021-00453
• Device Sequence Number: 4219364
• Product Code: KWQ
• UDI-Device Identifier: 04046963814175
• UDI-Public: 4046963814175
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K100243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: SC503T
• Device Catalogue Number: SC503T
• Device Lot Number: 52658139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention