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

Catalog Number UNK - CONSTRUCTS: PLATE/SCREWS

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: warnhoff, m.Et al.(2021), double plating - surgical technique and good clinical results in complex and highly unstable proximal humeral fractures, injury, vol.52, pages 2285-2291 (germany).The aim of this study was to evaluate an operative technique using an angular stable lateral plate supported by a one-third tubular plate positioned anteriorly at the lesser tuberosity for unstable proximal humeral fractures.Patients treated with a double plate osteosynthesis were included between january 2014 and december 2017.Thirty-one patients were treated with open reduction and internal fixation via locked plating (philos ¿proximal humeral plate, depuy synthes, umkirch, germany) and an additional one- third tubular plate (depuysynthes, umkirch, germany) at the lesser tuberosity.There were 19 males and 12 females with a mean age of 54.7 years ±12.1 (range, 26 ¿77 years).The mean follow-up was 30.9 months (range, 12-76 months).The following complications were reported as follows: 2 patients had died of unrelated causes.11 patients presented clinical signs of subacromial impingement, two of which already underwent implant removal.Both stated that implant removal benefitted them.Overall, 9 patients had their implants removed, 5 in combination with arthroscopic arthrolysis.Six of the 9 patients had a partial stiffness of the shoulder ranging from medium difficulties to se- vere lack of mobility.For 3 patients, the implant-removal was specifically requested by the patient without radiological or clin- ical correlate.All 9 patients stated that implant-removal and arthrolysis benefitted them.3 patients had fair results (56 - 70 points).3 patients had poor results (<56).A 46-year-old male patient had implant removal at 6 months post-op.A 46-year-old female patient had reverse arthroplasty because of necrosis of the humeral head at 32 months post-op.A 36-year-old male patient had reverse arthroplasty because of necrosis of the humeral head at 18 months post-op.A 60-year-old female patient had implant removal and arthrolysis at 9 months post-op.A 26-year-old male patient had implant removal and arthrolysis at 9 months post-op a 60-year-old female patient had implant removal and arthrolysis at 17 months post-op.A 43-year-old male patient had revision surgery due to neurolysis radial nerve at post-op day 1.A 52-year-old male patient had implant removal at 4 months post-op.A 45-year-old male patient had implant removal at 5 months post-op.A 66-year-old male patient had implant removal at 4 months post-op.A 39-year-old male patient had implant removal and arthrolysis at 7 months post-op a 57-year-old male patient had implant removal and arthrolysis at 4 months post-op a 25-year-old female patient had anatomic arthroplasty because of nonunion at 15 months post-op.This report is for an unknown synthes philos and a 1/3 tubular plate.This report captures the reported a 36-year-old male patient had reverse arthroplasty because of necrosis of the humeral head at 18 months post-op.A copy of the literature article is being submitted with this medwatch.This is report 11 of 15 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.510k: this report is for an unknown screw or plate/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Investigation summary: 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.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION
• 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: 14249767
• MDR Text Key: 294172210
• Report Number: 8030965-2022-02808
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: PLATE/SCREWS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• 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