MAUDE Adverse Event Report: AESCULAP AG ENDURO TIBIA HEMI-WEDGE T3 4MM RM/LL; KNEE ENDOPROSTHETICS

Model Number NB065K

Device Problem Packaging Problem (3007)

Patient Problem No Code Available (3191)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 enduro tibia.It was reported during the preparation of the sterile packed implants it was found that the double sterile packaging either was not properly sealed or the implant had damaged the packaging.Since the implant was only available once in the loan set, the tibia had to be re-prepared.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

The packaging processes in the responsible production department are validated.The packages itself will be reviewed by 100 per cent visual inspection within the production process.Therefore it is unlikely that the packages have left the production department in such a damaged condition.There are no hints that the packages was not sealed in a proper way.Probably the damages of the inner and outer sterile packaging was caused due to several shipping cycles to several hospitals.

• Brand Name: ENDURO TIBIA HEMI-WEDGE T3 4MM RM/LL
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10413982
• MDR Text Key: 207350476
• Report Number: 9610612-2020-00402
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB065K
• Device Catalogue Number: NB065K
• Device Lot Number: 52187555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention