MAUDE Adverse Event Report: KAIRISON SHAFT DET.UP 235MM 2MM; BONE PUNCHES, RONGEURS

Model Number FK882R

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/05/2021

Event Type  malfunction  

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 fk882r - kairison shaft det.Up 235mm 2mm.According to the complaint description, intrapoerative ends don't meet.There was no described patient harm.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).

Event Description

Additional information received on 04/07/2021.The device malfunction was noted by the surgical staff prior to use on the patient.The reporter added that there was a second set available for use, as such the 2mm kairison was removed from use and an alternative kairison readily available to use in the procedure.The surgery was successfully completed with no intraoperative issues or events.

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Nvestigation results: visual investigation: the investigation was carried out visually and microscopically.We made a visual inspection of the products.Here we found a bent downwards footplate, visible damage working end and a dent cutting edge of the wangler.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 2(5) probability of occurrence2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: the investigation shows different visible damages.We assume that this deformations and visible damages have been caused due to an overload situation during a previous procedure itself.This can be underlined by the dents we found during investigation, as this can be considered as a sign of an overloading situation.We were not able to detect any hint for a material defect or a production error.There is the possibility for a pre-damage due to other previous surgeries.Based upon the investigations results a capa is not necessary.

• Brand Name: KAIRISON SHAFT DET.UP 235MM 2MM
• Type of Device: BONE PUNCHES, RONGEURS
• MDR Report Key: 11618856
• MDR Text Key: 266743927
• Report Number: 9610612-2021-00265
• Device Sequence Number: 1
• Product Code: HAD
• UDI-Device Identifier: 04046963323516
• UDI-Public: 4046963323516
• Combination Product (y/n): N
• PMA/PMN Number: K062413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FK882R
• Device Catalogue Number: FK882R
• Device Lot Number: 4511875809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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