MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SPDPASS LARIAT W/NIT 25DEG RT; PASSER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/10/2014

Event Type  Injury  

Event Description

It was reported patient underwent an initial procedure on (b)(6) 2014.During the procedure, the tip of the speedpass lariat fractured inside the patient.The fractured tip was removed from the patient.

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.Dimensional evaluation found component to be within appropriate design specification.The root cause of the event could not be determined due to insufficient information.

• Brand Name: SPDPASS LARIAT W/NIT 25DEG RT
• Type of Device: PASSER
• 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: 3612176
• MDR Text Key: 4069726
• Report Number: 0001825034-2014-00729
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

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: 11/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 904012
• Device Lot Number: 523840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 02/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2009
• 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