MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFN; ROD, FIXATION, INTRAMEDULLARY

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

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374); Post Operative Wound Infection (2446); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfn constructs/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: bäcker, h.C.Et al (2022), breakage of intramedullary femoral nailing or femoral plating: how to prevent implant failure, european journal of medical research, vol.27 (7), pages 1-7 (germany).The aim of this retrospective study was to analyse the different causes of implant failure after femoral fracture fixation, including demographics, operative techniques, fracture pattern, the use of cerclage wires, and, if available, histology samples.Between 2011 to 2019, a total of 24 patients (15 male and 9 female) with femoral implant failures [either intramedullary nail (n=11) or plate breakage (n=13)] were included in the study.The overall mean age at time of implant failure was 65.7 ± 15.1 years.In im group, synthes proximal femoral nail (pfn) anti-rotation was used in 7 patients, synthes pfn in 1, a competitor in 2 patients, and unknown in 1 patient.A synthes cerclage wire system was applied in 6 patients.In the po group, synthes liss lcp femur plate was used in 12 and a dcp plate in 1.In 3 of these patients, a synthes cerclage wire system was applied.The following complications were reported as follows: im group: 8 patients (7 with pfna, 1 with pfn) had implant failure/femoral nail breakage occurred at a mean of 36.7 ± 20.3 weeks after initial surgery.All patients presented with sudden onset of pain in the hip, without any trauma.Non-union was observed in all cases.The most common location for implant failure is between two cerclages, as seen in 2 cases.In 3 cases, failure sites were close to the most proximal cerclage.In tumour patients, failure occurred at the site of the osteolysis and melanoma metastasis.In 4 patients where a cerclage fixation was performed, a dislocation in the fracture was seen.In an unknown patient, breakage was seen at the location of the cephalomedullary screw (n=3).In an unknown patient, the initial quality of reduction was slight displacement of 7 mm (n=4).In an unknown patient, the initial quality of reduction of 8 mm lateralisation was observed (n=1) on the anteroposterior plain radiographic imaging.Unknown number of patients had cerclage migration.In an unknown patient, the growth of either staphylococcus aureus (n=2) or streptococcus constellatus (n=1) was present.In addition, sonication revealed streptococcus constellatus (n=1) and cutibacterium acnes (n=1).Po group: 13 patients (12 with liss lcp, 1 with dcp) had implant failure/breakage occurred at a mean of 21.1 ± 18.9 weeks.Non-union was identified in every patient.In 3 patients, minor displacement was seen ranging between 3 and 7 mm on plain x-ray.Reduction was valgus in 3 cases, 1 in varus, and 1 had a loss of length.The typical location of implant failure was at the site of fracture close to or with a screw placed inside the fracture (53.8%; n = 7/13).In those cases, where cerclage wires were applied, the implant failure occurred at a location close to them in 23.1% (n = 3/13) of cases with cerclage dislocation.In the remaining cohort, plate breakage was observed for the fixation of an interprosthetic fracture between knee and hip prostheses (n = 2/13; 15.4%), or a progressive osteolysis due to clear cell renal cell carcinoma (7.7%, n = 1/13).The major predisposing factor was the placement of screws in almost every screw hole.Histology revealed infection in 2 cases, whereas microbiology cultures showed the growth of staphylococcus epidermidis in 2 cases and staphylococcus aureus in 1.Furthermore, sonication revealed the growth of staphylococcus hominis in 1 of the 3 cases.This report is for an unknown synthes pfn constructs.This report captures the reported dislocation in the fracture, the initial quality of reduction was slight displacement of 7 mm, the initial quality of reduction of 8 mm lateralization and infection.A copy of the literature article is being submitted with this medwatch.This is report 6 of 10 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13543535
• MDR Text Key: 289736087
• Report Number: 8030965-2022-00910
• Device Sequence Number: 1
• Product Code: HSB
• 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,Health Professional,Company Representative
• 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: 02/16/2022
• 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: 01/18/2022
• 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