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

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

Patient Problems Ossification (1428); Necrosis (1971); Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: 510k: this report is for an uunk - constructs: philos plate/screws/unknown lot.Part and lot numbers 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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

Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article: laflamme, g.-y.Et al (2021), novel technical factors affecting proximal humerus fixation stability, journal of orthopedic trauma, vol.35 (5), pages 259¿264 (canada).The primary objective of this retrospective radiological study is to assess the relationship between screw length and risk of screw cut-out and overall complications.Our secondary objective is to evaluate the importance of various orif technical characteristics as risk factors for screw cut-out and overall complications.Between january 2007 to december 2013, a total of 110 patients (32 male and 78 female) with a mean age of 60 years who underwent open reduction and internal fixation, were included in the study.Surgery was performed using philos locking plate (synthes usa, west chester, pa).The mean follow-up period was 2.5 years (range: 6 months¿5 years).The following complications were reported: 8 patients died.7 cases had an initial intra-articular screws / intraoperative screw penetration (defined as a technical error).20 patients were reoperated, among which 1 required screw removal, 14 required plate and screw removal, 2 required orif revision, and 3 for conversion to prosthetic replacement.28 patients had a loss of reduction with varus collapse of 10 degrees or more.3 patients had nonunion.1 patient had implant failure.7 patients had heterotopic ossification.15 patients had avn.10 of these patients had no screw perforation and 5 had screw cut-out leading to humeral head collapse.Of the 15 patients with avn, 9 chose a nonoperative treatment, 3 had complete implant removal, and 2 underwent arthroplasty.20 patients had screw cut-out.10 of the patients declined surgery, 4 had implant removal, 2 had repeated orif with bone graft, and 2 had a shoulder arthroplasty.This report is for an unknown synthes philos plate/screws constructs and unknown synthes philos screws.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - constructs: philos plate/screws.This report is 4 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: SCREW,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: 11977239
• MDR Text Key: 264803894
• Report Number: 2939274-2021-02880
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: 05/19/2021
• 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