MAUDE Adverse Event Report: BIOMET TRAUMA HIP FRACTURE NAIL RH 125 DEG 13MM X 400MM; FIXATION, ROD

Model Number N/A

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacture history has not been provided for review.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date ¿ ni.Manufacture date ¿ ni.

Event Description

During a right hip fracture nail fixation procedure, the nail would not attach to the jig.Another nail was used to complete the procedure with minimal delay and no patient injury.

Manufacturer Narrative

Visual review of the returned device shows some staining which was likely a result of the decontamination process.Furthermore, there does not appear to be damage to the nail.A dimensional analysis was completed on the proximal end of the nail that connects with the jig.Two (2) of the slots on the proximal end of the nail measured undersized as well as the opening that connects to the jig.The dimensional analysis confirmed the complaint.The device is considered to be nonconforming as dimensions were out of spec with no visible damage that would have caused the nonconformities.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause was determined to be a manufacturing issue.Corrective and preventive actions have been initiated as a result of the nonconformance.F 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.

• Brand Name: HIP FRACTURE NAIL RH 125 DEG 13MM X 400MM
• Type of Device: FIXATION, ROD
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6001057
• MDR Text Key: 56541873
• Report Number: 0001825034-2016-03947
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK100238
• 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,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 814313400
• Device Lot Number: DPFBWY
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2013
• 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