MAUDE Adverse Event Report: AESCULAP AG ABC SELF-LOCKING ASSISTANCE; SPINE SURGERY

Model Number FJ911R

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that there was an issue with fj911r - abc self-locking assistance.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) (9610612-2022-00325) fj932t.

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 Description

Associated medwatch reports: 400573257 (9610612-2022-00324) fj911r, 400573256 (9610612-2022-00325) fj932t.

• Brand Name: ABC SELF-LOCKING ASSISTANCE
• Type of Device: 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: 15781860
• MDR Text Key: 303567101
• Report Number: 9610612-2022-00324
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: FJ911R
• Device Catalogue Number: FJ911R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention