MAUDE Adverse Event Report: AESCULAP AG COLUMBUS IMPLANT HOLDING/INSERTION INSTR; INSTRUMENTS FOR KNEE ENDOPROST

Model Number NQ560R

Device Problems Disconnection (1171); Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Preliminary results: 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 columbus implant holding/insertion instr.According to the complaint description a screw disconnected intraoperatively and remained in patient.The screw loosened and disconnected completely from the instrument.It was left in the patient and went un-noticed until post surgery follow up x-ray.Initial surgery: (b)(6) 2020.Date of x-ray: (b)(6) 2020.A future surgery may be required for removal.Additional information was received: the device fragment has not moved and is not causing the patient discomfort at this time.The surgeon will continue to monitor the patient, but for now a revision has not been scheduled.The adverse event is filed under reference (b)(4).

Manufacturer Narrative

Investigation failure description according to the provided pictures: one screw of the holding instrument has come loose and is no longer fixed in the cover plate.Investigation no product at hand, therefore an investigation at the product is not possible.Pictorial documentation pictures were provided.A section of the instructions for use (ifu) was noted, which stated "fixation screws which connect the various components must not be disassembeled".Batch 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.Explanation and rationale on the basis of the current information and without a product for investigation, a clear conclusion cannot be drawn.It could be possible that the screws were unscrewed for the purpose of cleaning.It is possible to unscrew the fastened screws of the nq560r, but they are not designed for disassembling.The instrument is not meant to be opened for cleaning and the screws are therefore glued to the thread.By forcibly unscrewing the screws, the adhesive connection between the screw and the thread is dissolved/destroyed.The screw, which is screwed back in, can then loosen unintentionally after repeated use.On this issue there was a safety team meeting in march 2014.Among other things there was a change of the ifu.Furthermore it is also mentioned in the ifu that the device has to be checked for damages, loose parts etc.Conclusion and root cause see above.Corrective action safety team, change number: it can be assumed that the complained device was manufactured before the change/modification.

Event Description

Update: the patient has no discomfort.Reportedly, additional x-rays were taken and showed that the device fragment had not migrated.A revision surgery was not planned.

• Brand Name: COLUMBUS IMPLANT HOLDING/INSERTION INSTR
• Type of Device: INSTRUMENTS FOR KNEE ENDOPROST
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10295220
• MDR Text Key: 199535321
• Report Number: 2916714-2020-00246
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/20/2020,05/07/2021

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: NQ560R
• Device Catalogue Number: NQ560R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2020
• Distributor Facility Aware Date: 06/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention