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

Model Number FJ911R

Device Problem Fracture (1260)

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

Event Date 12/20/2023

Event Type  Injury  

Event Description

It was reported that there was an issue with the product fj911r - abc self-locking assistance.According to the complaint description, one of the locking pins did not come up when tightening the screws for the final time.The locking assist was screwed into the screw, but the tip came off and remained inside the locking pin.An additional medical intervention was required.Because the screw was firmly embedded in the bone, the bone near the screw was removed with a drill.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Further information was not provided.The adverse event is filed under aesculap ag reference no.(b)(4).Involved components: fj933t/ abc self-locking cervical screw 4.0x16mm - lot unknown, internal aesculap ag ref.No.(b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Manufacturer Narrative

Investigation results: the screw arrived with broken- off petals, the locking- assistant with broken off (threaded) tip.The broken- off tip was not included.A visual and microscopic investigation of the locking assistant was made.The threaded tip was broken off and there were some wear marks at the shaft.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to specifications valid at the time of production.Based on the production date of march 2015, it was possible to identify one batch for this period.This concerns the batch 52111775.Currently there are no further complaints with this lot and error pattern at hand.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: the fracture surface shows no signs of a torsion fracture as usual with these instruments.It is assumed that the break in this instrument was caused by a high tensile load (axial), but the root cause cannot finally concluded.There is no indication for a material defect or manufacturing failure.Based upon the investigation results, a capa is not required.

• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18531442
• MDR Text Key: 333087467
• Report Number: 9610612-2023-00287
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/26/2024

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: 12/20/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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
• Treatment: FJ933T - LOT UNKNOWN
• Patient Outcome(s): Required Intervention