MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MAXFIRE W/ ZIPLOOP; FASTENER, FIXATION

Model Number N/A

Device Problems Component Falling (1105); Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 12/06/2013

Event Type  Injury  

Event Description

It was reported patient underwent a meniscus repair procedure on (b)(6), 2013.During the procedure, the suture anchor was not securely bedded on the hook and fell off when the surgeon attempted to deploy the implant.The suture was cut and removed and a second implant was utilized to complete the procedure.

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.During the evaluation, the cause of the event was assessed to be due to inadvertent user error.The inserter was advanced while the cannula was not against the meniscus, therefore causing the insert to come off.

• Brand Name: MAXFIRE W/ ZIPLOOP
• Type of Device: FASTENER, FIXATION
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3556491
• MDR Text Key: 16680616
• Report Number: 0001825034-2013-06215
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111564
• 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
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 900339
• Device Lot Number: 330440
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2013
• 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