MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: EX-FIX; APPLIANCE, FIXATION, NAIL

Device Problem Device Slipped (1584)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: hennings r., spiegl u., fakler j., ahrberga., (2020) the ao triangular external fixator: a backup option in the treatment of ankle fractures in geriatric patients?, european journal of orthopaedic surgery & traumatology volume 31: pages 719¿727 (germany).This retrospective study aims to analyze the indications, complications, and radiographic short-term results of geriatric patients treated with ao triangular external fixators (aefs) as a definite treatment strategy.Between 2005 and 2015, 35 patients over 65 years of age who suffered from an ankle fracture (ao 44) which was initially stabilized with an ao triangular external fixator (aef) at a single level i trauma center were analyzed.16 patients (13 women, 3 men) with a mean age of 74 years (sd 6.2) were treated with aef until fracture healing, 9 with a single ao triangular external fixator (aef) and 7 with an ao hybrid external fixator (hef).The combination of with ao triangular external fixator (aefs) and at least one additional osteosynthesis of a malleolus was defined as a hybrid external fixator (hef).All aef corresponded to a pin and rod system and consisted of two percutaneously inserted schanz-type pins at the anterior tibial crest, one steinmann pin inserted horizontally through the calcaneal tuberosity, and two small pins in metatarsal 1 and 5 or 4, respectively.The frame is stabilized by carbon fiber rods.The combination of aef and a simultaneous osteosynthesis of at least one malleolus (medial, lateral, and/or posterior) was defined as ao hybrid external fixator.The osteosynthesis of the medial malleolus was done using either 3.5 mm cortical screws or kirschner-(k-)wires, and the fibula was stabilized using cortical screws (depuysynthes, warsaw, in, usa), k-wires between 1.6 and 2.5 mm (konigsee, allendorf, germany or b.Braun aesculap, tuttlingen, germany), intramedullary elastic nails (konigsee, allendorf, germany), and one-third tubular plates (depuysynthes, warsaw, in, usa).Reported complications: 69-year-old male , with aef fixator type, had poor radiographic outcome.Fig.1 69-year-old female patient suffered an ao 44b3 fracture (a, c).Due to poor state of the soft tissue, the fracture was stabilized with an aef on the day of trauma (b, d) fig.2 same patient as in fig.1.Due to lack of recovery of the soft tissues, conversion with additive osteosynthesis into secondary hef was performed 9 days after trauma (a, c).Aef removal 60 days after trauma with preserved congruity and joint space (b, d).70-year-old female , with aef fixator type, had loosening of the external fixator without surgical consequences was documented, and poor radiographic outcome.81-year-old male , with aef fixator type, had poor radiographic outcome.68-year-old female , with aef fixator type, had poor radiographic outcome.79-year-old female , with aef fixator type, had poor radiographic outcome.Pintract infection + lateral distal > 2 mm in aef.With surgical revision , calcaneotalotibk-wire stab (24) (day after beginning of aef therapy).68-year-old female , with aef fixator type, had lateral distal > 2 mm in aef.With surgical revision , conversion to ring fixator (11) (day after beginning of aef therapy), and poor radiographic outcome.72-year-old female, with aef fixator type, had fracture metatarsale i + v, loosening of aef.With surgical revision , ring fix calcaneotalotib.K-wire stab (15) (day after beginning of aef therapy), and poor radiographic outcome.74-year-old female, with aef fixator type, had pintract infection and bleeding at pin.Fig.4 68-year-old female patient suffered an ao 44b3 fracture (same patient as in fig.3.) definite treatment with aef was indicated due to the lack of soft tissue healing.A, c show lateral subluxation 60 days into therapy.Posttraumatic arthrosis with lateral incongruity was established 90 days after trauma and aef removal after fracture healing (b, d).This report is for unknown synthes ao external fixator.This is report 4 of 6 for complaint (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.This report is for an unknown constructs: ex-fix/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.

• Brand Name: UNK - CONSTRUCTS: EX-FIX
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 15594987
• MDR Text Key: 301643958
• Report Number: 8030965-2022-08125
• Device Sequence Number: 1
• Product Code: KTT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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: 09/22/2022
• 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