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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2013

Event Type  malfunction  

Event Description

It was reported that patient underwent a bunnionectomy utilizing a pin on (b)(6) 2013.During the procedure, the pin fractured upon insertion.Another pin was utilized to complete the procedure with no injury to 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.(note: biomet, inc.Acquired the trauma product line from depuy orthopaedics, inc.(¿depuy¿) on june 16, 2012 (¿closing date¿).Pursuant to the written agreement between biomet and depuy, biomet agreed to be responsible for regulatory reporting for events which occurred after the closing date regardless of the entity that actually manufactured the product or actually sold the product to the healthcare provider.Because the product that is the subject matter was manufactured before the closing date, please be advised that the subject product was manufactured by depuy and not biomet.) depuy also sold the product that is the subject matter to the healthcare provider involved.

Manufacturer Narrative

Examination of returned device found no evidence of product non-conformance.Evaluation of device found evidence that failure mode was likely due to misuse by implant being put through excessive force or over torqued, and/or not inspected for wear and disfigurement which may have prevented the use of the implant and its failure.

• 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: amanda zajicek ; 56 e. bell drive; warsaw, IN 46582 ; 5743726782
• MDR Report Key: 3579727
• MDR Text Key: 18806913
• Report Number: 0001825034-2014-00434
• 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,Followup
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 841070
• Device Lot Number: 326136
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2013
• 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