MAUDE Adverse Event Report: AESCULAP AG ABC SELF-LOCKING CERVICAL SCREW 4.0X14MM; SPINE SURGERY

Model Number	FJ932T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that there was an issue with fj932t - abc self-locking cervical screw 4.0x14mm.According to the complainant, the screw was being locked-in when the top broke off.This occurred during an anterior cervical discectomy and fusion (acdf) procedure.Patient harm was unknown.There was no surgical delay.Further details have been requested.The adverse event is filed under aag reference: (b)(4).
Event or Problem Description
Update: patient harm updated to none from unknown.
Additional Manufacturer Narrative
Additional information: h6 - codes updated investigation: up to now, there is no sample available for analysis, therefore an analysis cannot be carried out.Device 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 preventive measures: due to the fact that on the one hand there is no sample for analysis and on the other hand the error description is not meaningful enough, the risk analysis is not applicable in this case.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 investigation results, a capa is not necessary.

• Brand Name: ABC SELF-LOCKING CERVICAL SCREW 4.0X14MM
• Common Device Name: 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15849967
• Report Number: 9610612-2022-00344
• Device Sequence Number: 14758815
• Product Code: KWQ
• UDI-Device Identifier: 04038653445028
• UDI-Public: 4038653445028
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: FJ932T
• Device Catalogue Number: FJ932T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown