MAUDE Adverse Event Report: SYNTHES GMBH UNK - CABLE/WIRE: CERCLAGE CABLE; CERCLAGE, FIXATION

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown cable with crimp (ø 1.7 mm)/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: lim e.J., kim j.J., kim k.H., kim j.W., (2021) surgical outcomes of retrograde nailing enhanced with minimally invasive cerclage cable fixation for infra-isthmal femoral fracture, journal of orthopaedic science xxx (xxxx) xxx (korea, south) this single-center, retrospective, observational study aims to evaluate the surgical outcomes of retrograde nailing enhanced with minimally invasive cerclage cable fixation for infra-isthmal femoral fracture.Between 2013 and 2017, a total 15 patients (3 men and 12 women) with a mean age of 71.6 years (range 35-86 years) from a hospital registry with 745 patients with infra-isthmal fractures treated with retrograde nailing and minimally invasive cerclage cable fixation were included in this study.Cable with crimp (ø 1.7 mm; synthes) is used for the cerclage technique.The following nails were used: distal femoral nail (dfn), tdm, cannulated femoral nail (cfn).Radiographs of femur in anteroposterior (ap) and lateral views were taken at initial visit, immediately postoperatively, and at 4, 8, 12, 16, 24 weeks, 9 months, and 12 months after surgery.The following complications were reported as follows: a case of an (b)(6) year-old female (case no.1) treated with dfn required additional dynamization surgery.-a case of an (b)(6) year-old female (case no.13) treated with dfn required additional dynamization surgery.-a case of a (b)(6) year-old male (case no.15) treated with dfn required additional dynamization surgery.-a case of an (b)(6) year-old female patient (case no.2) demonstrated abrupt displacement after nailing, where dfn nail was used, despite reduction cable.The reduction cable achieved anatomical reduction of the fracture site before nailing in the infra-isthmal peri-prosthetic spiral femur fracture, but abrupt displacement occurred, which was caused by the posteriorly skewed direction of the open box design of the femoral component.With 22.0 mm mm displacement of main fragment.(fig.5) a case of a (b)(6) year-old female patient (case no.6) demonstrated wedge fragment after nailing, where dfn nail was used.The proximal portion of the wedge fragment was encompassed by the reduction cable, but displacement of the distal portion was not prevented, resulting in displacement of the wedge fragment during nailing.(fig.6) this report is for an unknown synthes cable with crimp (ø 1.7 mm).This report captures a case of a (b)(6) year-old female patient (case no.6) demonstrated wedge fragment after nailing, where dfn nail was used.The proximal portion of the wedge fragment was encompassed by the reduction cable, but displacement of the distal portion was not prevented, resulting in displacement of the wedge fragment during nailing.(fig.6).This is report 12 of 12 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.H3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 - CABLE/WIRE: CERCLAGE CABLE
• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12469195
• MDR Text Key: 271334986
• Report Number: 8030965-2021-07737
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Patient Sequence Number: 1
• Patient Age: 59 YR