MAUDE Adverse Event Report: BIOMET ORTHOPEDICS DISP NITINOL NDL SINGLE PACK; SPORTS MED INSTRUMENTATION

Model Number N/A

Device Problems Fracture (1260); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 03/17/2015

Event Type  Injury  

Event Description

It was reported patient underwent a right rotator cuff repair procedure on (b)(6) 2015.During the procedure, the needle tip fractured after twelve to fifteen passes.Another needle was used and the tip fractured after twenty passes.Free and fixed needles were utilized to complete the procedure.It is unknown if patient retained a foreign body.

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 complaint related anomaly or deviation.

• Brand Name: DISP NITINOL NDL SINGLE PACK
• Type of Device: SPORTS MED INSTRUMENTATION
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4695577
• MDR Text Key: 5673055
• Report Number: 0001825034-2015-01513
• Device Sequence Number: 1
• Product Code: HXO
• 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
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 110010851
• Device Lot Number: 990730
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2015
• 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