MAUDE Adverse Event Report: AESCULAP AG S4 SET SCREW NEW VERSION; IMPLANTS POSTERIOR STABILISATI

Model Number	SW790T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
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 sw790t - s4 set screw new version.According to the complaint description, there was an operative breakage of set screw.The set screw was damaged when the set screw was fastened.The thread of the set screw was damaged and the debris was recovered.The customer replaced it with a new set screw and was able to fasten it.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: S4 SET SCREW NEW VERSION
• Common Device Name: IMPLANTS POSTERIOR STABILISATI
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12258884
• Report Number: 9610612-2021-00515
• Device Sequence Number: 3682045
• Product Code: MNI
• UDI-Device Identifier: 04038653455256
• UDI-Public: 4038653455256
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SW790T
• Device Catalogue Number: SW790T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/19/2021
• 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