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

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
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with sc503t - quintex semiconstrained screw 4.0x16mm.According to the complaint description, the 16mm quintex screw x3 upon seating the screw, the inner silver bushing kept popping out.This happened on 3 consecutive 16mm screws.We switched to 14mm screws and they worked just fine.This was prior to the screw being fully seated into the plate and while the screwdriver was still engaged in the screw.There was no surgery delay, the only intervention was switching the screws and the patient outcome was good.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00453 (400515657 + sc503t).
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) 9610612-2021-00453 (400515657 + sc503t).

• Brand Name: QUINTEX SEMICONSTRAINED SCREW 4.0X16MM
• Common Device Name: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11960488
• Report Number: 9610612-2021-00428
• Device Sequence Number: 19768589
• 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
• 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: 52644089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• 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: 06/08/2021
• 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