MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number N/A

Device Problems Unstable (1667); Migration (4003)

Patient Problem Joint Laxity (4526)

Event Date 08/22/2013

Event Type  Injury  

Event Description

It was reported patient was revised approximately 10 days post implantation due to instability under mobilization ending in a secondary dislocation of the nail.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: 47249532011 62266723 tibial nail - yellow 11 mm diameter 32 cm length use red proximal and red distal screws; 47248403050 62321950 5.0 mm diameter cortical screw; 47248403550 62330386 5.0 mm diameter cortical screw; 47248403550 62340928 5.0 mm diameter cortical screw; 47248403050 62321950 5.0 mm diameter cortical screw; 47248405250 62214118 5.0 mm diameter cortical screw; 47248403550 62321879 5.0 mm diameter cortical screw.Report source: foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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: 0001822565-2021-02531, 0001822565-2021-03070, 0001822565-2021-03542, 0001822565-2021-03543, 0001822565-2021-03544, 0001822565-2021-03547.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review of the available records identified initial surgery noted poor bone quality additional cross-locking proximally.Revision surgery due to nail, plate must be attached obliquely, dorsolateral fragment remains.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12968181
• MDR Text Key: 281991680
• Report Number: 0001822565-2021-03546
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 47248405250
• Device Lot Number: 62214118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2012
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 90 KG