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 Arthritis (1723); Pain (1994); No Code Available (3191)

Event Date 12/31/2013

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes 3.5 mm one-third-tubular locking plate/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.(b)(4).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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: stahel p.Et al (2013).Safe surgical technique: reconstruction of the sternoclavicular joint for posttraumatic arthritis after posterior sternoclavicular dislocation.Patient safety in surgery.Volume 7.Page 1-11.(usa).This study describes a successful salvage procedure by partial resection of the medial clavicle and ligamentous reconstruction of the sternoclavicular joint with a figure-of-eight semitendinosus allograft interposition arthroplasty.This is a case report on a (b)(6) man who sustained a fall on his left shoulder in a skiing accident.He was in significant pain and shortness of breath.A chest radiograph was unremarkable and particularly revealed no evidence of pneumothorax, hemothorax, or widened mediastinum (figure 3).Due to significant tenderness over the left sternoclavicular joint, a ct scan was obtained which demonstrated a locked posterior sternoclavicular dislocation (figure 4).On the emergency department, the patient complained of significant pain in his chest and left shoulder, as well as left-sided neck pain.Due to the locked position of the clavicle behind the manubrium (figure 4), no attempt for a closed reduction maneuver was made.The patient underwent open reduction and internal fixation with bridge plating of the left sternoclavicular joint using an unknown synthes 3.5 mm one-third-tubular locking plate.The plate was placed on the anterior/superior border of the medial clavicle and spanned across the midline of the manubrium (figure 6a).An on-table chest radiograph was obtained to rule out an iatrogenic left-side pneumothorax (figure 6c).The patient tolerated the procedure well and reported minimal postoperative pain.His left shoulder was immobilized in a sling for pain control, followed by gradual mobilization with pendulum exercises.On a postoperative day 1, the patient was discharged from the hospital.He appeared to have an excellent subjective outcome with a full and painless range of motion in the left shoulder.At 2 months post-injury, the patient underwent early removal of the unknown synthes 3.5 mm one-third-tubular locking plate.The patient initially continued to have an uneventful recovery, unrestricted in his daily activities.Within 6 months, however, he started developing progressive, ultimately excruciating pain over the left sternoclavicular joint, dramatically restricting his daily functional activities.The symptoms deteriorated to a point at which the patient awakened from sleep every hour secondary to pain.The symptoms were refractory to the chronic intake of non-steroidal inflammatory agents (ibuprofen).At 9 months post-injury, a follow-up ct scan revealed significant posttraumatic arthritis of the left sternoclavicular joint, in conjunction with recurrent posterior subluxation of the medial clavicle (figure 7).The patient underwent re-operation with anterior ligamentous complex reconstruction in conjunction with partial resection of the medial clavicular head proximal to the insertion of the costoclavicular ligament.This report is for a patient who experienced pain and arthritis post-operatively requiring revision surgery.This report is for an unknown synthes 3.5 mm one-third-tubular locking plate.This is report 1 of 2 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: 8592554
• MDR Text Key: 144469249
• Report Number: 2939274-2019-57903
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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: 04/10/2019
• 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