MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE EZ PASS 30 DEGREE LEFT; PASSER

Catalog Number 904056

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported during a labral repair, the wire inside the device jammed and would not advance.Due to the inability to slide the wire with the thumb wheel, the device had to be pulled from the patient.A competitor¿s device was used and repositioned within the patient to finish the case.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

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.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed based on limited information received.The ez pass appears to be in good shape with no visible signs of damage.The nitinol component is completely separated from the ez pass making it impossible to recreate the event.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined with the available information.Review of the complaint history determined that no further action is required.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

The following report is submitted to relay additional information.(b)(4).

• Brand Name: EZ PASS 30 DEGREE LEFT
• Type of Device: PASSER
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6456596
• MDR Text Key: 71616226
• Report Number: 0001825034-2017-02360
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/04/2019
• Device Catalogue Number: 904056
• Device Lot Number: 776230
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR