MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Nerve Damage (1979); Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown dynamic compression plate/screws construct/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.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

The aim of this study is to evaluate the effect of total wrist arthrodesis on both general and upper-extremity¿specific health status in patients treated for posttraumatic wrist arthritis.Over a 15-year period, a total of 22 patients (16 male and 6 female) with an average age of 58 years (range, 20-78 years) underwent total wrist arthrodesis.A plate and screws were used to stabilize the arthrodesis in 20 patients (17 dynamic compression plates and 3 plates designed specifically for wrist arthrodesis [synthes, paoli, pa]) and 2 patients had arthrodesis using screws only.The mean follow-up period was unknown.The following complications were reported: 1 patient died.5 patients had elective removal of implants for extensor tendon irritation.14 patients reported persistent pain.4 patients reported severe pain.1 of these patients reported the pain to be worse after the fusion and the remaining patients reported that the pain was improved by the surgery.2 patients with severe pain had ongoing ulnar nerve dysfunction at the time of the follow-up evaluation.2 patients reported severe pain on the dash questionnaire, also reported mild dissatisfaction with the fusion.This report is for an unknown synthes dynamic compression plate/screws constructs, unknown synthes wrist arthrodesis dorsal plate, and unknown synthes screws.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: DYNAMIC COMPRESSION PLATE/SCREWS
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11731973
• MDR Text Key: 247534842
• Report Number: 2939274-2021-02090
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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: 04/02/2021
• 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