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

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

Patient Problems Pain (1994); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown button 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: shi., et al (2015) failure of the lesser tuberosity osteotomy after total shoulder arthroplasty, journal of shoulder and elbow surgery volume 24, pages 203-209 (usa).This study aims to present a series of patients who underwent tsa using the lto technique and subsequently had failure at the osteotomy site.Between february 2010 and september 2011, a total of 5 patients , all men, mean age of this group of patients was 52 years (range, 42 to 63 years), who had nonunion of the lto site after tsa were retrospectively reviewed.Shoulder prosthesis was used and lto was repaired with 5 no.5 fiberwire sutures (arthrex, naples, fl, usa).The mean total length of follow-up after the initial tsa was 29 months (range, 24 to 38 months).The mean time from the index procedure to revision surgery was 14 weeks (range, 7 to 28 weeks).Revision repair of lto with multiple fiberwire sutures and button plate laterally.The sutures were then passed in pairs through a synthes rotator cuff plate (depuy synthes,warsaw, in, usa) and tied down.A case of a (b)(6) year old male (patient no.5) required 4 additional procedures after the lto fixation: removal of the button plate at latest follow-up after revision.A case of a (b)(6) year old male (patient no.1) required repeat lto fixation 3 months after the initial fixation.The humeral head was downsized to decrease the anterior impingement on the subscapularis at latest follow-up after revision.A case of a (b)(6) year old male (patient no.3) had a supraspinatus and infraspinatus tear 8 months after the lto fixation procedure; arthroscopic repair failed, and he ultimately underwent revision to reverse arthroplasty at latest follow-up after revision.A case of a (b)(6) year old male (patient no.4) has persistent pain and weakness; his examination showed increased passive er and a markedly positive belly-press sign.At his latest follow-up, he deferred undergoing reverse arthroplasty at the latest follow-up.At his latest follow-up, he deferred undergoing reverse arthroplasty at latest follow-up after revision.This report is for an unknown synthes button plate.It captures a case of a 50 year old male (patient no.4) has persistent pain and weakness; his examination showed increased passive er and a markedly positive belly-press sign.At his latest follow-up, he deferred undergoing reverse arthroplasty at the latest follow-up.At his latest follow-up, he deferred undergoing reverse arthroplasty at latest follow-up after revision.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10491449
• MDR Text Key: 205692742
• Report Number: 2939274-2020-03983
• 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: Physician
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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: 08/11/2020
• 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: 50 YR