MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Bone Fracture(s) (1870); Necrosis (1971)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: siebenbürger, g.Et al.(2021), screw-tip augmented locked plating versus primary reverse total shoulder arthroplasty in displaced proximal humeral fractures: a retrospective comparative cohort study with a mean follow-up of 39 months, geriatric orthopaedic surgery & rehabilitation, volume 12, pages 1¿8 (germany).This study compared the clinical and radiologic outcomes of screw-tip augmented locking plate osteosynthesis (sta) vs primary reverse total shoulder arthroplasty (rsa) in elderly patients with displaced proximal humeral fractures.Between april 2014 and october 2016, 60 patients (age >65 years) with a displaced proximal humeral fracture underwent open reduction and internal fixation with locking plate and fluoroscopy controlled screw-tip augmentation.All patients were implanted with a philos plate.Twenty-two patients underwent rsa while 38 patients underwent sta using cannulated screws and augmentation was then performed using polymethylmethacrylate (pmma, trauma cem v+®, depuy synthes gmbh, zuchwil, switzerland or calcium phosphate cement, quickset, arthrex inc., naples, fl, usa) the following complications were reported as follows: sta 14 patients died within the follow-up period.5 patients had revision surgery (2 revision osteosynthesis, 1 case of conversion to rsa).4 cases had secondary displacement >10°.4 cases had avn.This is report 1 of 2 for (b)(4).This report is for an unknown synthes philos plate/screw construct.(fracture, necrosis).

Manufacturer Narrative

Date of event: unknown event date.Brand name, common device name, manufacturer name, city, and state, lot #, pma/510k: this report is for an unknown philos construct/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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.

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14831690
• MDR Text Key: 294794485
• Report Number: 8030965-2022-04374
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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: 05/30/2022
• 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