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

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.

Event Description

It was reported that patient underwent a bunionectomy on an unknown date.During the procedure, a saw was used to flush cut the pin.It was noted that the pin will break if it is pulled too hard.No additional information has been provided.

Manufacturer Narrative

This follow-up report is being filed to relay corrected information.

Event Description

It was reported that patient underwent a bunionectomy on (b)(6) 2015.During the procedure, a saw was used to flush cut the pin.It was noted that the pin will break if it is pulled too hard.No additional information has been provided.

Manufacturer Narrative

This follow up report is being filed to relay corrected information.

Event Description

It was reported that patient underwent a bunionectomy.During the procedure, the pin fractured, and a saw was used to flush cut the pin.It was noted that the pin will break if it is pulled too hard.No additional information has been provided.

• Brand Name: ORTHOSORB LS 1.3MM TPRD PN 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: 5261261
• MDR Text Key: 32524752
• Report Number: 0001825034-2015-04824
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 110010745
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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