MAUDE Adverse Event Report: BIOMET TRAUMA AFFIXUS HIP FRACTURE NAIL - RIGHT 130 DEGREES; ROD, FIXATION

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

Pt identifier: - (b)(6).Concomitant medical product: - insertion jig 125 degree, cat#: 211201200 lot#: ni.Hfn rh 130 deg 11mm x 320mm, cat#: 814511320 lot#: 5491807.T-handle hudson, cat#: 281001004 lot#: ni.A 5.0mm hex driver long, cat#: 281001037 lot#: ni.Insertion jig 130 degree, cat#: 211201201 lot#: cx3227m01.Product has been 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: 0001825034-2017-06648 and 0001825034-2017-06649.

Event Description

It was reported that during a hip fracture repair nailing procedure, the jig could not be disassembled from the implanted nail.This caused the surgeon to remove both the lag screw and hip fracture nail from the patient.A 125 degree nail was successfully implanted, but the lag screw hole had to be expanded to accommodate a different angle.There was an approximate thirty (30) minute delay to the procedure.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.The returned devices are one insertion jig bolt, pn 211201202 ln so2001775, one hfn rh 130 deg 11mm x 340mm, pn 814511340 ln 214510, and one insertion jig 130 degree, pn 211201201 ln cx3227m01.A postmarket surveillance technician was able to remove the reported nail from the targeting jig with a moderate amount of force.Visual examination showed a considerable amount of biological matter on the threads of the jig bolt, but no visible damage.Once the both and the nail were cleaned, they assembled and disassembled without issue.Dhr was reviewed and no discrepancies relevant to the reported event were found.Based on the fact that the devices mated as expected once cleaned, it is believed the biological matter on the jig bolt caused it to stick.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: AFFIXUS HIP FRACTURE NAIL - RIGHT 130 DEGREES
• Type of Device: ROD, FIXATION
• 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: 6825781
• MDR Text Key: 83830909
• Report Number: 0001825034-2017-06648
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 814511340
• Device Lot Number: 214510
• 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
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR