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

Model Number	FJ932T
Medical Device Problem Code	Compatibility Problem (2960)
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 that there was an issue with fj932t - abc self-locking cervical screw 4.0x14mm.According to the complainant, the abc screw inner locking ring did not raise into locking position when screw driver was disengaged.Surgeon then attempted to use the locking assistance tool.The working threads broke off inside the locking ring and the inner silver locking ring hex head became stripped.Various universal removal instruments were also used in the attempt.Finally, five (5) successfully implanted screws had to be removed; the stripped screw was removed with locking pliers, and plate and screw insertions were initiated again.An additional medical intervention was required.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch reports: (b)(4) (9610612-2022-00324) fj911r.(b)(4) fj932t.
Additional Manufacturer Narrative
Investigation: there is no sample available, therefore an investigation could not performed.According to the failure description the threaded tip of the instrument broke off.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.The current failure rate is within the risk analysis and therefore acceptable according to din en iso 14971; severity is 6(10) and probability is 3(10).Conclusion and preventive measures: because the complained error- pattern is well known, a statistical analysis and evaluation is possible.According to the problem description, we assume, that the threaded tip is broken- off.Based upon the investigation results, a capa is not necessary.
Event or Problem Description
Associated medwatch reports: 400573257 (9610612-2022-00324) fj911r, 400573256 (9610612-2022-00325) fj932t.

• 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: 15781876
• Report Number: 9610612-2022-00325
• Device Sequence Number: 20115524
• Product Code: KWQ
• UDI-Device Identifier: 04038653445028
• UDI-Public: 4038653445028
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FJ932T
• Device Catalogue Number: FJ932T
• Device Lot Number: 52755458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown