MAUDE Adverse Event Report: BIOMET TRAUMA ORTHOSORB LS 1.3MM TPRD PN KIT; PIN, FIXATION

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/28/2015

Event Type  Injury  

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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 3 states, ¿bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing.¿.

Event Description

It was reported that patient underwent a foot procedure on (b)(6) 2015.During the procedure, a pin crumbled when inserted into the patient's foot.All pieces were retrieved from the patient, a k-wire was used, and an additional hole was created to complete the procedure.

• Brand Name: ORTHOSORB LS 1.3MM TPRD PN KIT
• Type of Device: PIN, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 5364318
• MDR Text Key: 35816446
• Report Number: 0001825034-2016-00149
• Device Sequence Number: 1
• Product Code: OVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140625
• 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: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 110010745
• Device Lot Number: 768100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 16 YR