MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE,FIXATION,NAIL

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

Patient Problems Bone Fracture(s) (1870); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unk - constructs: dhs/dcs/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.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

This report is being filed after the review of the following journal article: kusen j.Q.Et al (2021), efficacy of two integrated geriatric care pathways for the treatment of hip fractures: a cross-cultural comparison, european journal of trauma and emergency surgery, vol.Xx (xx), pages 1-10 (switzerland/netherlands).This cross-national dual centre cohort study was made to compare between two trauma geriatric care models, one swiss (ch) and one dutch (nl), to assess whether these models would perform similarly despite the possible differences in local clinical practices.Between 2014 to 2015, a total of 752 patients (aged 70 and above) who were treated surgically in either netherlands (n=513; 143 male and 370 female; mean age of 85 years) or switzerland (ch) hospital (n=239; 60 male and 179 female; mean age of 86 years) were included in the study.Type of implants used includes plate osteosynthesis (unknown), hemiarthroplasty (unknown), intramedullary nail (unknown), sliding hip screw [including dynamic hip screw by depuy synthes, oberdorf switzerland and competitor device] and the use of cannulated screws by depuy synthes, oberdorf switzerland.The sliding hip screw was used in 22 patients in ch and 43 patients in ch, while the cannulated screws was used in nl only in 17 patients.In ch, routine follow-up took place 6 weeks, 3 months and 1 year post-operatively.In the nl, routine follow-up usually took place 6 weeks after surgery and, if no complications occurred, a consult by phone was performed at 3 months post-operatively.In selected cases, no follow-up took place due to comorbidities.The following complications were reported as follows: switzerland (ch): an unknown number of patients with synthes device had a complicated course (n=104).An unknown number of patients with synthes device had = 1 surgical interventions secondary to bleeding (n=1), fracture (n=4), deep surgical site infection (n=3), inadequate post-operative outcome/reduction in post-operative radiograph requiring revision surgery (n=8), and implant dislocation (n=5).An unknown number of patients with synthes device died at 30-days (n=27), 90-days (n=42), and at 1-year postoperatively (n=61).Netherland (nl): an unknown number of patients with synthes device had a complicated course (n=263).An unknown number of patients with synthes device had = 1 surgical interventions secondary to bleeding (n=1), fracture (n=10), deep surgical site infection (n=14), inadequate post-operative outcome/reduction in post-operative radiograph requiring revision surgery (n=3), and implant dislocation (n=4).An unknown number of patients with synthes device died at 30-days (n=43), 90-days (n=88), and at 1-year postoperatively (n=146).This report is for an unknown synthes dhs constructs.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - constructs: dhs/dcs.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13695294
• MDR Text Key: 291292882
• Report Number: 8030965-2022-01445
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention