MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: kalmar, c.L.Et al (2022), surgical and nonsurgical factors associated with salvaging exposed vertical expandable prosthetic titanium rib hardware, plastic and reconstructive surgery, vol.149 (3), pages 485e-495e (usa).The aim of this study is to examine surgical and nonsurgical factors associated with successful salvage of veptr exposure.Between 2014 and 2020, a prospective institutional database was queried for patients with veptr hardware complications who required soft-tissue reconstruction.Hardware salvage was considered successful if reconstruction allowed the hardware to be retained until the next veptr expansion.The following complications were reported as follows: 58 patients required management of veptr hardware complications.Because of the severity of the wound complications, 10 of 58 patients (17.2 percent) required immediate hardware removal before soft-tissue coverage, leaving 48 of 58 patients (82.8 percent) undergoing attempted hardware salvage.Indications for flap coverage were threatened exposure [22 of 58 (37.9 percent)] and exposed hardware [36 of 58 (62.1 percent)].Exposed hardware was significantly more likely to require immediate removal and resulted in unsuccessful hardware salvage.Patients with either fecal or urinary incontinence were significantly more likely to present with infected wounds [p = 0.028; 24 of 46 (52.2 percent), versus two of 12 (16.7 percent)].Clinical suspicion for infection was documented in 26 of 58 patients (44.8 percent), with 19 of 58 (32.8 percent) having positive wound culture data available.The most common organism genus was staphylococcus [13 of 19 (68.4 percent)] in those with culture data available.This report is for an unknown synthes veptr.This is report 1 of 1 for complaint (b)(4).

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.510k: this report is for an unknown constructs: veptr/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15349732
• MDR Text Key: 299183941
• Report Number: 2939274-2022-03405
• Device Sequence Number: 1
• Product Code: MDI
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention