MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE MAXFIRE WITH ZIPLOOP; FASTENER, FIXATION

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Activation, Positioning or Separation Problem (2906); Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 05/05/2017

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 that during a meniscal repair of the knee, the anchor was protruding out of the end of the inserter prior to the surgeon deploying the anchor.Subsequently, the reported anchor did not hold in the tissue and pulled out upon attempted deployment.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.The reported event could not be confirmed based on limited information received.Product was returned; however, anchor assembly was not returned.Therefore a functional check could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

It is reported that during a meniscal repair of the knee, the anchor was protruding out of the end of the inserter prior to the surgeon deploying the anchor, and was not seated on the needle inserter.Subsequently, the reported anchor did not hold in the tissue and pulled out upon attempted deployment.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: MAXFIRE WITH ZIPLOOP
• Type of Device: FASTENER, FIXATION
• 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: 6691382
• MDR Text Key: 79231354
• Report Number: 0001825034-2017-04572
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK111564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 900339
• Device Lot Number: 233360
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• 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
• Patient Outcome(s): Required Intervention