MAUDE Adverse Event Report: BIOMET TRAUMA UNKNOWN BIOMET AFFIXUS HIP FRACTURE NAIL INSERTION JIG BOLT

Model Number N/A

Device Problems Failure to Disconnect (2541); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Medical product - insertion jig 125 degree, cat#: 211201200 lot#: e73df4.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05191.

Event Description

It was reported that during a hip fracture nailing procedure, the connecting jig bolt was locked in the nail and could not be dislodged or removed.As a result, the entire system had to be removed from the patient.A competitor product was used to complete the procedure with minimal delay.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The returned device is one 125-degree affixus hip fracture nail, pn 814309180 ln 5550103, along with the associated 125-degree targeting jig and connecting bolt.Visually, the nail and jig are unremarkable, with a small amount of cosmetic wear likely due to implantation, explantation, and sterilization.The connecting bolt shows wear - but not to the point of being stripped.Functional testing reveals the bolt to be fused to the nail, confirming this complaint.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history could not be performed, as the part and lot numbers are unknown.Root cause was unable to be determined.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.

• Brand Name: UNKNOWN BIOMET AFFIXUS HIP FRACTURE NAIL INSERTION JIG BOLT
• 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: 6739503
• MDR Text Key: 80873136
• Report Number: 0001825034-2017-05197
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PEXEMPT
• 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,Followup
• Report Date: 01/09/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 07/28/2017; 01/08/2018
• Supplement Dates FDA Received: 08/24/2017; 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR