MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI-DBLE LEAD CORT 5.0X44MM SCR; ORTHOPEDIC BONE SCREW

Catalog Number 14-405044

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem No Information (3190)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: ti-dble lead cort 5.0x40mm scr, cat#14-405040, lot#ni.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 - 2020 - 01491.

Event Description

It has been reported the patient underwent an unknown procedure.Approximately 3 months later the patient was revised due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

D4: (b)(4).D11: ti-dble lead cort 5.0x44mm scr cat#14-405044 lot#ni, unk screw cat#ni lot#ni.

Event Description

It has been reported that the patient had a phoenix ankle arthrodesis nail system implanted to replace a failed competitor ankle system.Subsequently, the patient was revised approximately 3 months later to replace 2 backed out distal screws and a fractured calcaneus screw.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified no visible thread damage.The anodize has faded from wear.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: ankle orthopedic hardware with a tibial intramedullary rod with two backed out screws extending into the lateral malleolus soft tissues.Intramedullary rod extends into the hind foot also with a fractured calcaneal screw seen on the lateral film.Presumed posttraumatic changes of the distal tibia.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.

Event Description

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

• Brand Name: TI-DBLE LEAD CORT 5.0X44MM SCR
• Type of Device: ORTHOPEDIC BONE SCREW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9937634
• MDR Text Key: 191532678
• Report Number: 0001825034-2020-01492
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K063570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-405044
• Device Lot Number: 457920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention