MAUDE Adverse Event Report: AESCULAP AG UNIVATION X GAP MANAGEMENT SPACER 9+10MM; KNEE ENDOPROSTHETICS

Model Number NM652R

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation on going.Additional information / results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with univation x gap management spacer 9+10mm.According to the customer description, it was reported that laser inscription "start" for setting up the saw block is missing on univation probespacer 10mm this leads to uncertainty of the user and can be a significant source of error.If the saw block is not placed correctly, the femoral preparation cuts are not correct.There was no patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: UNIVATION X GAP MANAGEMENT SPACER 9+10MM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10627306
• MDR Text Key: 209822683
• Report Number: 9610612-2020-00614
• Device Sequence Number: 1
• Product Code: HWT
• 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
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM652R
• Device Catalogue Number: NM652R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention