MAUDE Adverse Event Report: AESCULAP AG ABC SELF-LOCKING ASSISTANCE; INSTRUMENTS CERVICAL STABILISATION

Model Number	FJ911R
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
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 to aesculap inc.That a abc self-locking assistance4.0x14mm (item # fj911r) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the silver locking ring did not raise to lock the screw in place when the screw driver was disengaged.It was reported that the threads of a locking assistance tool had broken off inside the locking ring, causing the screw to become stripped.The complaint device has been returned to the manufacturer for evaluation.As a result of this event additional medical intervention was reported.The surgeon had to remove five (5) successfully implanted screws and removed the stripped screw with locking pliers.The adverse event / malfunction is filed under aic reference cc (b)(4).The associated medwatch reports #: 2916714-2022-00108 (b)(4).
Additional Manufacturer Narrative
Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
Investigation complete.

• Brand Name: ABC SELF-LOCKING ASSISTANCE
• Common Device Name: INSTRUMENTS CERVICAL STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15751796
• Report Number: 2916714-2022-00109
• Device Sequence Number: 17722538
• Product Code: HXX
• UDI-Device Identifier: 04038653449941
• UDI-Public: 4038653449941
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023
• Report Date (Section F): 11/08/2022

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: FJ911R
• Device Catalogue Number: FJ911R
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 08/30/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/08/2022