MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 6.0 MM DIAMETER CANCELLOUS SCREW - BLACK PARTIALLY THREADED 3.5 MM HEX HEAD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)

Event Date 06/12/2015

Event Type  Injury  

Event Description

It was reported patient was revised due to bone fracture and wound healing defect approximately one month post implantation.It was reported patient experienced wound healing defect of the right knee with exposed osteosynthesis material.The patient underwent wound débridement, necrectomy, lavagae, vac installation.Four days later, debridement, lavage, vac change, then another four days later, defect coverage using free microvascular anastomosed latissimus dorsi flap, split skin graft and positioning fixator.One month later, tangential wound debridement and repeat split skin grafting.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This is a combination product (b)(4).Concomitant products: 47249432011 62745903 retrograde femoral nail - purple 11.5 mm diameterï ½ 32 cm length use red proximal screws and black distal fixed angle screws; 47248404560 62858594 6.0 mm diameter cancellous screw ï ½ black ï ½ fixed angle 3.5 mm hex head 45 mm length; 47248405060 62836167 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head; 47248404560 62858594 6.0 mm diameter cancellous screw ï ½ black ï ½ fixed angle 3.5 mm hex head 45 mm length; 47248403250 62924118 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; 47248403250 62944830 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; 47248405060 62743904 6.0 mm diameter cancellous screw - black fixed angle 3.5 mm hex head; 47248307060 61238422 6.0 mm diameter cancellous screw - black partially threaded 3.5 mm hex head.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 - 02726, 0001822565 - 2021 - 03548, 0001822565 - 2021 - 03551, 0001822565 - 2021 - 03552, 0001822565 - 2021 - 03553, 0001822565 - 2021 - 03554, 0001822565 - 2021 - 03555.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6.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 for massive decollement lower extremity on both sides.Revision confirmed, however no notes were provided.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: 6.0 MM DIAMETER CANCELLOUS SCREW - BLACK PARTIALLY THREADED 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: 12969161
• MDR Text Key: 281996855
• Report Number: 0001822565-2021-03556
• 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: 01/14/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 47248307060
• Device Lot Number: 61238422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 90 KG