MAUDE Adverse Event Report: AESCULAP AG ABC/QUINTEX FIXATION PIN SINGLE STERILE; SPINE SURGERY

Model Number FJ833RS

Device Problem Fracture (1260)

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

Event Date 12/05/2023

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 the product fj833rs - abc/quintex fixation pin single sterile.According to the complaint description, the device broke after it was inserted and removed several times.This occurred during an intervertebral fusion c4-c7.All fragments were retrieved from the patient's body.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: a microscopical visual inspection of the provided two pieces was made (the broken pin).Here it was found that the minor piece (the screw driver shaped tip) was bent and the blade warped.Following this, the fracture surfaces were examined, both the smaller and the larger fragment.Here were found heavy traces of corrosion and beyond the corrosion, the typical signs of a forced fracture were noted.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 our specification valid at the time of production.There are no similar complaints against the same lot number.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 necessary.Conclusion/preventive measures: the bending and the fracture surface are signs for unusually strong forces.Furthermore in the complaint text was noticed, that the pin was used several times (assumed to be in the same surgery).The instructions for use (ifu) points out that the pin may only be used once ("breakage or bending of the abc / quintex temporary fixation pins due to repeated application" according to ifu document number: (b)(4) change no.58).A material failure or a production error can be ruled out.As shown in the statistics, this is the only error of this type in this lot (which contains 597 pcs.) and in the last five years.Based on these facts, we assume a user error as the cause of the failure in this complaint.Based upon the investigation results, a capa is not required.

• Brand Name: ABC/QUINTEX FIXATION PIN SINGLE STERILE
• 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: 18409704
• MDR Text Key: 331513761
• Report Number: 9610612-2023-00276
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FJ833RS
• Device Catalogue Number: FJ833RS
• Device Lot Number: 52835734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention