MAUDE Adverse Event Report: AESCULAP AG S4C SET SCREW NEW VERSION; SPINE SURGERY

Model Number SW003T

Device Problem Fracture (1260)

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

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with sw003t - s4c set screw new version.According to the complaint description, the 90mm rod was cut in half and used in the original surgery, placing each half in each side of the construct.There was no accident, but on a recent scan after a change in patient symptoms, it was shown that the right side rod had broken completely in half.Revision surgery was completed, the rods were both removed, the polyaxial screws were still stable, so the surgeon put new rods and set screws in, with some distraction.A revision surgery was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information/ correction: b5 - added new leading material, updated involved component.D10 - involved component added.H3 - device evaluation.H6 - codes updated.Investigation results: visual investigation: two rods arrived in common with four set screws.All parts arrived in decontaminated condition.One of the rods is broke in two pieces.We made a visual inspection of the fracture surfaces of both ends of the fractured rod.Here we found the typically signs of a fatigue- fracture with forced fracture.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 7(10) x probability 2(10) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: the fracture surfaces of the broken rod showing no signs of a material failure like foreign inclusions or blowholes.The bendingpoint of the second, non-broken rod shows no hints for material weakness like compression waves or cracks.So we assume, that the preparations by the surgeon were flawless.We assume, that the patient behaviour was the most probable root cause.According to our dhr and pms investigations, there are no other similar cases at hand, so that a material or manufacturing related root cause can be ruled out.Conclusion and measures / preventive measures: based upon the investigation results the root cause is most probably patient related.There is no indication for a material-,manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Updated: leading material became an involved component.The new leading material is sw196t - s4c rod 3.5x90mm (b)(6).The adverse event is filed under aag reference (b)(4), (b)(6).Involved components: sw003t - s4c set screw new version - lot 52612527 (b)(6).

• Brand Name: S4C SET SCREW NEW VERSION
• 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: 16708693
• MDR Text Key: 312980829
• Report Number: 9610612-2023-00068
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050979
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW003T
• Device Catalogue Number: SW003T
• Device Lot Number: 52612527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SW003T - LOT 52612527
• Patient Outcome(s): Required Intervention