MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: SMALL FRAGMENT LCP; PLATE, FIXATION, BONE

Device Problem Material Deformation (2976)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this report is for an unknown plates: small fragment lcp/unknown lot.Part and lot numbers are unknown; udi 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

Device report from synthes reports an event in the (b)(6) as follows: this report is being filed after the review of the following journal article: lu v., zhang j., zhou a., and krkovic m.(2022), management of post traumatic femoral defects with a monorail external fixator over an intramedullary nail, european journal of orthopaedic surgery & traumatology, vol.32 (xx), pages 1119¿1126 (united kingdom).The aim of this retrospective study is to assess outcomes of post-traumatic femoral defects managed by monorail external fixation over an intramedullary nail.Between january 2013 and january 2021, a total of 8 male patients, with an average age of 37.75 years, who underwent treatment with monorail fixator-assisted intramedullary nailing were included in the study.Depuy synthes lateral femoral nails or retrograde/antegrade femoral nails were inserted in a retrograde (4 patients) and antegrade (4 patients) fashion to the blumensaat¿s line.When the transported fragment has docked with the distal fragment, the limb was still shorter than the contralateral one.Hence, the nail was kept unlocked at one end, such that further limb lengthening could be done to achieve equal limb length.Only then was the docking site compressed with the monorail, and the nail locked.The transported fragment was then secured in the docking site either utilizing nail locking screw options, or with a depuy synthes small fragment locking plate.Microbiology samples were taken again.After docking site union was secured, the monorail external fixator was removed.Mean follow-up time was 227 weeks (range 154¿331).The following complications were reported as follows: patient 1 (27-year-old male): had myositis ossificans¿pin sites bent.Patient 2 (23-year-old male): had pin site infection and was treated with one week of oral flucloxacillin; docking site nonunion.Patient 3 (63-year-old male): cellulitis¿osteomyelitis¿stage 3 osteoarthritis.Patient 4 (58-year-old male): pin site infection and was treated with one week of oral flucloxacillin; osteomyelitis -the osteomyelitis (patients 3 and 4) was treated by six weeks of intravenous vancomycin and teicoplanin in one patient, removal of infected metalwork with antibiotic-loaded calcium sulphate beads in another patient.Patient 5 (32-year-old male): had poor asami bone scores due to docking site nonunion, necessitating reamed intramedullary exchange nailing and docking site compression; extreme pain patient 6 (27-year-old male): pin site infection and was treated with one week of oral flucloxacillin; pins moved position¿plate bending patient 7 (29-year-old male): pin site infection and was treated with one week of oral flucloxacillin patient 8 (43-year-old male): had pin site infection with cellulitis and was treated with one week of oral flucloxacillin; poor asami bone scores due to docking site non-union, necessitating reamed intramedullary exchange nailing and docking site compression.A copy of the literature article is being submitted with this medwatch.This report involves one unk - plates: small fragment lcp.This is report 9 of 9 for (b)(4).

• Brand Name: UNK - PLATES: SMALL FRAGMENT LCP
• Type of Device: PLATE, FIXATION, BONE
• 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: 15471737
• MDR Text Key: 300557452
• Report Number: 8030965-2022-07258
• Device Sequence Number: 1
• Product Code: HRS
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 11/10/2022
• 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
• Patient Age: 27 YR
• Patient Sex: Male