MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: MATRIXRIB PLATE, FIXATION, BONE

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. If the information is unknown, not available or does not apply, the section/field of the form is left blank. This report is for an unknown device/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: ashley, d. W. Et al (2022), prospective randomized trial of metal vs resorbable plates in surgical stabilization of rib fractures, journal of trauma and acute care surgery, vol. Xx (xx), pages 1-50 (usa). The aim of this prospective interventional randomized controlled clinical observational study was to compare metal (titanium alloy) and resorbable plate rib fracture stabilization in trauma patients. Between january 20, 2020 to may 4, 2020, a total of 30 patients (20 were males; mean age of 53. 9 years) were randomized to metal or resorbable depending on the plate used for surgical fixation. Of these, 15 patients (metal group; 9 were males; mean age of 54 years) were implanted with metal (titanium alloy) plates (depuy synthes matrixrib fixation system; synthes usa, monument, co), while 15 patients (resorbable group; 11 were males; mean age of 53. 7 years) were implanted with a competitor resorbable polylactic acid plates. Total ribs plated 167 (88 metal/79 resorbable). The mean follow-up period was unknown. The following complications were reported as follows: metal group: 1 screw dislodgement was observed. This report is for an unk - screw: matrixrib. This is report 1 of 1 for (b)(4).

• Brand Name: UNK - SCREWS: MATRIXRIB
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 14958497
• Report Number: 2939274-2022-02550
• 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: Literature

Reporter Occupation

• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown
• Patient Sex: No Answer Provided