MAUDE Adverse Event Report: BIOMET ORTHOPEDICS ORTHOSORB 1 PIN 50X1.3MM KIT; PIN, FIXATION

Model Number N/A

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent right foot third digit arthroplasty on (b)(6) 2014.During the procedure, the surgeon put in the k-wire and when the orthosorb pin slid in, the k-wire came undone.Another orthosorb pin was used to complete the procedure with no delay or patient injury.

Manufacturer Narrative

Device not implanted/explanted.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.

• Brand Name: ORTHOSORB 1 PIN 50X1.3MM KIT
• Type of Device: PIN, 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 4141127
• MDR Text Key: 4796822
• Report Number: 0001825034-2014-07966
• Device Sequence Number: 1
• Product Code: OVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111077
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 841070
• Device Lot Number: 310584
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2013
• 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