MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 9-10MM SHORT EZLOC FEM FIXATN; FASTENER, FIXATION

Model Number N/A

Device Problems Device Slipped (1584); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that patient underwent an acl repair procedure utilizing a fixation device on (b)(6) 2014.During the procedure, the sutures on the device appeared to be loose and it could not be advanced through the tibial tunnel.Another device was available to complete the procedure without delay.

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.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

Examination of returned device found evidence of product non-conformance.Component was manufactured prior to current specifications.Work instructions detailing the assembly process and fixtures facilitating the assembly have been initiated to address the reported issue.

• Brand Name: 9-10MM SHORT EZLOC FEM FIXATN
• 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: 3841337
• MDR Text Key: 19762420
• Report Number: 0001825034-2014-05032
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK041261
• 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: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 904789
• Device Lot Number: 857330
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 05/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2010
• 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