MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE, FIXATION, BONE

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown tubular plate/unknown lot.Part and lot number 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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: wiggers, j.K.And ring, d.(2011), osteonecrosis after open reduction and internal fixation of a bicolumnar fracture of the distal humerus: a report of four cases, the journal of hand surgery, vol.36a (1), pages 89-93, doi: 10.1016/j.Jhsa.2010.09.001 (usa).The aim of this study is to bring attention to the complications after an open reduction and internal fixation of a fracture involving both the medial and lateral columns of the distal humerus above the base of the olecranon fossa.A total of 4 patients were treated with an open reduction and internal fixation of a bicolumnar fracture of the distal humerus.Out of 4, only 2 patients used a 3.5-mm reconstruction plates and screws (synthes, paoli, pa) and a 3.5-mm reconstruction plates and a tubular plate (synthes).The following complications were reported: a (b)(6) year-old woman who had bicolumnar right distal humerus fracture (ao type 13-c3.2) after a fall from a standing height, was treated with open reduction and internal fixation with direct medial and posterolateral 3.5-mm reconstruction plates and screws (synthes, paoli, pa).Two months after surgery, the lateral plate fractured and there was a nonunion of the fracture (fig.1b).Upon removal of the medial plate, it was evident that the medial epicondyle was completely avascular and necrotic (fig.1c).It was essentially the consistency of gritty toothpaste.In retrospect, dissolution of the medial epicondyle was apparent on radiographs (fig.1b).There were no signs of infection.The necrotic bone was removed, and a total elbow arthroplasty was performed.A (b)(6) year-old woman who had fracture of left distal humerus (ao type 13-c2.2 bicolumnar fracture) underwent open reduction and internal fixation through an olecranon osteotomy using medial and lateral 3.5-mm reconstruction plates and a third plate placed posterolaterally (a third tubular plate; all plates from synthes).The fracture healed, and the patient regained good range of motion.Seven months after the fracture, the postoperative radiographs showed advanced degenerative changes involving the entire elbow joint but no evidence of implant loosening or infection.Two years postoperatively, radiographs showed interval articular bone resorption, subluxation of the elbow, and migration of one of the k-wires that was used for olecranon osteotomy fixation.A debridement was performed and there is no growth on cultures.The medial and lateral columns were healed, but there was substantial osteonecrosis of the articular surface.The implants were removed, and the elbow was debrided of devitalized and inflammatory tissue.This report is for an unknown synthes tubular plate.This is report 4 of 5 for (b)(4).

• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8611919
• MDR Text Key: 145112656
• Report Number: 2939274-2019-58039
• 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: Physician
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• 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
• Date Manufacturer Received: 04/17/2019
• 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
• Patient Age: 76 YR