MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE; PLATE, FIXATION, BONE

Catalog Number UNK_WWA

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 07/21/2022

Event Type  Injury  

Event Description

The post market clinical team has conducted a follow-up report on ¿a retrospective data collection of fracture fixation, revision procedures, joint fusion, and bone reconstruction in the foot and toes with the ortholoc 3di hallux plating system¿.The study was conducted at 'cooper university hospital, cooper bone and joint institute, usa'.The report is associated with the stryker ¿ortholoc 3di hallux plating system¿ and includes an analysis of the clinical data that was collected on 46 patients.The cases in the study range from january 1, 2010, to august 31, 2021.The report indicates that 5 patients experienced nonunion.

Manufacturer Narrative

The reported event of nonunion could not be confirmed, since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.     if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The post market clinical team has conducted a follow-up report on ¿a retrospective data collection of fracture fixation, revision procedures, joint fusion, and bone reconstruction in the foot and toes with the ortholoc 3di hallux plating system¿.The study was conducted at (b)(6) hospital, (b)(6) institute, usa'.The report is associated with the stryker ¿ortholoc 3di hallux plating system¿ and includes an analysis of the clinical data that was collected on 46 patients.The cases in the study range from january 1, 2010, to august 31, 2021.The report indicates that 5 patients experienced nonunion.

Manufacturer Narrative

Please note correction to product code and common device name.

• Brand Name: UNKNOWN GRAVITY SYNCHFIX SYNDESMOSIS FIXATION DEVICE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15240564
• MDR Text Key: 298047231
• Report Number: 3010667733-2022-00271
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 10/12/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other