MAUDE Adverse Event Report: AESCULAP AG ENDURO TIBIA TRIAL/PREPARATION PLAT.T1; INSTRUMENTS FOR KNEE ENDOPROST

Model Number NP451R

Device Problem Lack of Maintenance Documentation or Guidelines (2971)

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

Event Date 02/19/2021

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 np451r - enduro tibia trial/preparation plat.T1 according to the complaint description, during surgery the missing marks were noticed.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).

Manufacturer Narrative

Based upon investigation results, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.Investigation results: visual investigation: the device was examined microscopically and visually.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 x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

The malfunction is filed under aag reference (b)(4).

• Brand Name: ENDURO TIBIA TRIAL/PREPARATION PLAT.T1
• Type of Device: INSTRUMENTS FOR KNEE ENDOPROST
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11497292
• MDR Text Key: 253217445
• Report Number: 9610612-2021-00203
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 04046963419509
• UDI-Public: 4046963419509
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NP451R
• Device Catalogue Number: NP451R
• Device Lot Number: 52622743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1