MAUDE Adverse Event Report: BIOMET TRAUMA UNKNOWN BIOMET DVR VOLAR SCREW; FIXATION, SCREW

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 02/02/2014

Event Type  Injury  

Manufacturer Narrative

(b)(6).Yoram a.Weil *, rami mosheiff, shimon firman, meir liebergall, amal khoury.¿outcome of delayed primary internal fixation of distal radius fractures.A comparative study¿.Injury, int.J.Care injured 45 (2014) 960¿964.The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06328.

Event Description

It was reported in a journal article that one (1) case of postoperative subsidence of the joint was observed that resulted in a prominent screw, following a distal volar radius trauma plating procedure.Removal of the components caused improvement of symptoms.No further information has been provided.

• Brand Name: UNKNOWN BIOMET DVR VOLAR SCREW
• Type of Device: FIXATION, SCREW
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6798437
• MDR Text Key: 82840765
• Report Number: 0001825034-2017-06330
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/16/2017
• 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): Hospitalization; Required Intervention