MAUDE Adverse Event Report: AESCULAP AG COLUMBUS TIBIAL TRIAL/PREP.PLAT.HOLDER; KNEE ENDOPROSTHETICS

Model Number NQ378R

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/26/2020

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 columbus tibial trial.It was reported that the pin was broken off during the surgery.There was a surgical delay.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4),.

Manufacturer Narrative

B5 - clarification received.Based upon the new information, that there are no surgery delay and no patient harm we evaluated this case as not being reportable.The report was reassessed and found to no longer require submission.

Event Description

Clarification was received: there was no surgical delay.There was no medical intervention necessary.The pin on the end of the holder had snapped off.

• Brand Name: COLUMBUS TIBIAL TRIAL/PREP.PLAT.HOLDER
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10168330
• MDR Text Key: 201011885
• Report Number: 9610612-2020-00209
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/28/2020

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: NQ378R
• Device Catalogue Number: NQ378R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention