MAUDE Adverse Event Report: BIOMET UK LTD. BIOMED OXFORD TIBIA 2 RK; UNKNOWN

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Information (3190)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that when opening the sterile sieves, heavy moisture/humidity was seen on the biomed oxford tibia 2 rk of rk-b201-012-on.The patient was already under anesthesia and had to be discharged due to the wet sieve.The op was moved.A patient risk with respect to the wet sieve cannot be excluded.

Event Description

It was reported that when opening the sterile sieves, heavy moisture/humidity was seen on the biomed oxford tibia 2 rk of rk-b201-012- on.The patient was already under anesthesia and had to be discharged due to the wet sieve.The op was moved.A patient risk with respect to the wet sieve cannot be excluded.

Manufacturer Narrative

(b)(4).Upon investigation it has been determined that the reported event was related to sterilisation of the products and not related to any manufacturing or design defect or malfunction of the reported instrument set.Zimmer biomet was not responsible for sterilisation and packaging of the instrument set in question.

• Brand Name: BIOMED OXFORD TIBIA 2 RK
• Type of Device: UNKNOWN
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8160880
• MDR Text Key: 130260200
• Report Number: 3002806535-2018-01272
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1