MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZNN LOCKING SCREWS; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pain (1994)

Event Date 07/15/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: im nail; znn locking screw.Foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was retained by the attorney.The investigation is in process.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: 0001822565 - 2021 - 00862.

Event Description

It was reported patient underwent an initial bilateral femoral im nail insertion.During the inpatient stay, the patient complained of pain over the distal locking screws on the left side.Due to the length of the screws, the patient was returned to the or two days post implantation to exchange the screws for shorter ones.Additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was confirmed by review of medical records received.Review of the available records identified the patient complained of pain after surgery to insert locking pins in the left thigh.A revision surgery was performed to change the pins to shorter ones.The surgeon notes very long distal locking pins in the post-operative x-ray.The patient experienced regular wound healing, was given physical therapy, and was able to mobilize on crutches.During the hospital stay, the patient was given 2 units of blood.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN ZNN LOCKING SCREWS
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11574298
• MDR Text Key: 242398523
• Report Number: 0001822565-2021-00815
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 74