MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: garala k., et al (2022) distal femoral fractures: a comparison between single lateral plate fixation and a combined femoral nail and plate fixation, injury 53 (2022) 634¿639 (united kingdom).This study aims to compare outcomes of fixation of distal femoral fractures using single lateral plate (slp) fixation versus nail and plate fixation (npf) for primary fracture fixation.Between august 2016 to august 2020, patients with previous fixation for femoral neck fractures or metalwork from hip or knee arthroplasty were included in the study.67 patients with distal femoral fractures (3 bilateral) were treated by slp or npf.3 patients were excluded as they had complex open fractures with significant bone loss.Therefore 64 patients were included in the study (17 males and 47 females).The age range was 22 to 102 years old with a mean age of 68 years.Patients were divided into 2 operative groups: slp with 40 patients (13 males and 27 females) and npf with 27 patients (5 males and 22 females).2 patients in the npf group and 1 patient in the slp group were bilateral.During single lateral plating (slp), fixation was achieved using a synthes distal femoral locking condylar plate (lcp) (west chester, pa 19380) or the synthes variable angled locking condylar plate (va-lcp) (west chester, pa 19380) augmented with cables or screws outside the plate where deemed necessary.For nail and plate fixation (npf).Combined retrograde femoral nailing and lateral plating (minimally invasive lateral incisions for the plate) were performed in all cases.The implant used for npf was the titanium synthes expert retrograde/anterograde femoral nail (west chester, pa 19380) and synthes variable angled distal femur lcp.The average follow-up time was 29 months (range from 6 to 56 months).Slp group: -1 30-day mortality.There were 11 non-unions.All required revision surgery.5 other return to theatre including manipulation under anesthetic for stiffness debridement and washout for wound infection.7 patients experienced subsequent metalwork failure due to a non-union.Fig.3 demonstrates an example of a well reduced fracture treated by slp which subsequently didn¿t unite, and the metalwork failed.Radiograph demonstrating a failure of plate fixation following satisfactory reduction and fixation.Npf group: 1 30-day mortality.1 other returned to the theatre for the further procedure for backing out of a distal locking blade.This report is for an unknown synthes titanium synthes expert retrograde/anterograde femoral nail, unknown synthes variable angled distal femur lcp, unknown synthes distal femoral locking condylar plate (lcp), and unknown synthes variable angled locking condylar plate (va-lcp).This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Brand name, common device name, manufacture name, city and state, lot #, pma/510k: this report is for an unknown device/unknown lot.Part and lot number 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, device 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.(b)(4).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 - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 14550780
• MDR Text Key: 293074848
• Report Number: 8030965-2022-03582
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• 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