MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: LOCKING; SCREW,FIXATION,BONE

Device Problem Migration (4003)

Patient Problems Deformity/ Disfigurement (2360); Malunion of Bone (4529)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: liu, c.Et al (2023), the double plate fixation technique prevents varus collapse in ao type c3 supra intercondylar fracture of the distal femur, archives of orthopaedic and trauma surgery, pages 1-9, (taiwan).The purpose of this study was to assess the incidence of varus collapse after treating complex supra-intercondylar fractures of the distal femur (ao type c3) using a single plate (sp) or double plate (dp) fixation technique.We retrospectively reviewed 357 patients with distal femoral fractures who were treated at our hospital between 2006 and 2017.There were 54 patients enrolled into this study with age from 15 to 85 years old (mean 41.6, sd=19.9), and 32 of them were open fractures (59%).The patients were further divided into either an sp (n=15) or a dp group (n=39).A distal femoral locking plate (liss, synthes) was then applied on the lateral side of the femur via limited open reduction technique.An additional buttress plate on the medial side was applied according to the surgeon¿s preference (df lcp, synthes, paoli, pa, u.S.A.).The wound was then closed layer-by-layer.Neither splinting nor knee bracing was performed after surgery.The patients were followed up for a mean of 41.8 months after the operation (47.9 months in the sp group and 39.4 months in the dp group, p = 0.182).The following complications reported as follows: for the sp group: 6 nonunion, 1 nonunion with hardware failure, 2 varus collapse with nonunion, 2 varus collapse with malunion, 1 avascular necrosis, and 2 plate malposition.For the dp group: 8 nonunion, 5 nonunion with hardware failure, 1 varus collapse with malunion, 7 joint stiff, 1 plate malposition, 1 wound dehiscence, and 1 superficial infection.14 nonunion cases, 6 and 8 in the sp and dp groups, respectively.All nonunion cases underwent revision osteosynthesis surgery.Among the 14 cases, 2 underwent revision osteosynthesis with dynamic condylar screw plus medial buttress plate and 4 with synthes lateral locking plate plus medial buttress plate and autologous bone grafting at a mean of 16 months after the first operation (range 9¿23 months).Bony union was achieved at a mean of 6 months after revision surgery (range 3¿16 months).For the other eight nonunion cases, autologous bone grafting was performed at a mean of 11 months after the osteosynthesis surgery (range 6¿18 months), and bony union was achieved at a mean of 12 months after the operation (range 6¿18 months).In the three varus malunion patients, the mean ldfa change compared to the immediately postoperative change was 7° (11°, 5°, and 5° in each patient) (fig.2 and 3) a 27-year-old male patient (sp) had a radiographs (fig.2) that showed varus collapse with loosed screws over the femoral shaft at 27 months after the operation; malunion with varus deformity at 90 months.The change of ldfa was 11°.A 50-year-old male patient (sp) had a radiographs (fig.2) that showed a varus collapse of the medial femoral condyle with malunion at 14 months after the operation.The change of ldfa was 5° a 59-year-old male patient (dp) had a radiographs (fig.3) that the fracture was collapsed and the medial buttress plate was loosed at 21 months.The change of lfda was 5°.This report is for an unknown locking screws (depuy synthes).It captures reported 27-year-old male patient (sp) who had a radiographs (fig.2) that showed varus collapse with loosed screws over the femoral shaft at 27 months after the operation; malunion with varus deformity at 90 months.The change of ldfa was 11°.A copy of the literature article is being submitted with this medwatch.This is report 6 of 10 for (b)(4).

Manufacturer Narrative

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.D1, d2, d3, d4, g4-510k: this report is for an unknown locking screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 - SCREWS: LOCKING
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18384259
• MDR Text Key: 331293909
• Report Number: 8030965-2023-16099
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/22/2023
• 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: 11/30/2023
• 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
• Patient Age: 27 YR
• Patient Sex: Male