MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RETRO FEM CONNECTING BOLT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 03/27/2014

Event Type  Injury  

Manufacturer Narrative

Evaluation of device revealed threads of the instrument were damaged.Evaluation of device suggests the instruments were likely damaged after initial distribution.Root cause for the reported event determined to be damage to the instruments.

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.Product is being returned to manufacturer, but has not yet been received.Upon completion of evaluation, a follow up report will be sent to the fda.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2014-03129 / 03130).

Event Description

It was reported that patient underwent a fixed femoral fracture procedure on (b)(6) 2014.During the procedure, while the surgeon used the slap hammer, the targeting device disconnected from the nail.The nail was engaged several times with the same results.An additional connecting bolt was attempted for use with the same results.Surgeon completed the procedure manually.This caused a delay of greater than 30 minutes in the procedure.

• Brand Name: RETRO FEM CONNECTING BOLT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 3772328
• MDR Text Key: 18711435
• Report Number: 0001825034-2014-03130
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 14-442021
• Device Lot Number: 372530
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 04/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 59