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

Model Number	FJ911R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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 fj911r - abc self-locking assistance.According to the complaint description, the instrument broke during surgery.Working end of locking assistance tool broke off in screw head while in use.Both pieces of locking assistance tool removed from patient.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event 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: ABC SELF-LOCKING ASSISTANCE
• Common Device Name: INSTRUMENTS CERVICAL STABILISA
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12647853
• Report Number: 9610612-2021-00661
• Device Sequence Number: 13738131
• Product Code: HXX
• UDI-Device Identifier: 04038653449941
• UDI-Public: 4038653449941
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/23/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5102923
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown