MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE POWERPUMP DAY CASSETTE 10PK; ARTHROSCOPE

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.

Event Description

During a procedure, it was noticed that there was a small crack in the power pump cassette causing it to leak.Another cassette was used to complete the procedure without delay.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The device was forwarded to the supplier for evaluation.Supplier found there was a crack in the upper part of the cassette housing close to the frosted tubing, i.E.It is visible that a piece of the plastic is missing in the upper corner.It was relayed that this breakage will cause the cassette to leak during pressurization.The supplier further relayed that this is most likely generated during loading of the cassette to the pump machine.However, complaint investigation relays that the customer states the proper technique was utilized and the product was placed with little force.Therefore, root cause cannot be determined.Device history records were reviewed and indicate the device was manufactured according to proper specifications.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: POWERPUMP DAY CASSETTE 10PK
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6114071
• MDR Text Key: 60430276
• Report Number: 0001825034-2016-04739
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK093409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 941012
• Device Lot Number: 15E05
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1